nabumetone

Generic Name: nabumetone (na BUE me tone)

Brand Names: Relafen

What is nabumetone?

Nabumetone is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Nabumetone is used to treat pain or inflammation caused by arthritis.

Nabumetone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about nabumetone?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use nabumetone. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking nabumetone. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to nabumetone (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking nabumetone. Alcohol can increase the risk of stomach bleeding caused by nabumetone. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Nabumetone can make your skin more sensitive to sunlight and sunburn may result.

What should I discuss with my healthcare provider before taking nabumetone?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to nabumetone, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking nabumetone, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  a history of heart attack, stroke, or blood clot;

  
  


• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  a history of stomach ulcers or bleeding;

  
  


• liver or kidney disease,


• 
  

  asthma;

  
  


• 
  

  polyps in your nose;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  if you smoke.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take nabumetone.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking nabumetone during the last 3 months of pregnancy may harm the unborn baby. Do not take nabumetone during pregnancy unless your doctor has told you to. It is not known whether nabumetone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

How should I take nabumetone?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you take nabumetone for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store nabumetone at room temperature away from moisture and heat.

See also: Nabumetone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking nabumetone?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to nabumetone (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking nabumetone. Alcohol can increase the risk of stomach bleeding caused by nabumetone. Avoid prolonged exposure to sunlight. Nabumetone may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Nabumetone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking nabumetone and seek medical attention or call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  swelling or rapid weight gain;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  
  


• 
  

  bruising, severe tingling, numbness, pain, muscle weakness.

  
  

Less serious side effects may include:

• 
  

  upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

  
  


• 
  

  bloating, gas;

  
  


• 
  

  dizziness, headache, nervousness;

  
  


• 
  

  skin itching or rash;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  ringing in your ears.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nabumetone Dosing Information

Usual Adult Dose for Osteoarthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

What other drugs will affect nabumetone?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with nabumetone may cause you to bruise or bleed easily.

Before taking nabumetone, tell your doctor if you are taking any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  diuretics (water pills) such as furosemide (Lasix);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

  
  

This list is not complete and there may be other drugs that can interact with nabumetone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More nabumetone resources

• Nabumetone Side Effects (in more detail)
• Nabumetone Dosage
• Nabumetone Use in Pregnancy & Breastfeeding
• Drug Images
• Nabumetone Drug Interactions
• Nabumetone Support Group
• 30 Reviews for Nabumetone - Add your own review/rating

• nabumetone Advanced Consumer (Micromedex) - Includes Dosage Information


• Nabumetone Prescribing Information (FDA)


• Nabumetone Professional Patient Advice (Wolters Kluwer)


• Nabumetone Monograph (AHFS DI)


• Nabumetone MedFacts Consumer Leaflet (Wolters Kluwer)


• Relafen Consumer Overview


• Relafen Prescribing Information (FDA)

Compare nabumetone with other medications

• Back Pain
• Frozen Shoulder
• Muscle Pain
• Osteoarthritis
• Rheumatoid Arthritis
• Sciatica

Where can I get more information?

• Your pharmacist can provide more information about nabumetone.

See also: nabumetone side effects (in more detail)

Nystatin Cream

Pronunciation: nye-STAT-in
Generic Name: Nystatin
Brand Name: Pediaderm AF

Nystatin Cream is used for:

Treating certain fungal infections that cause diaper rash. It may also be used for other conditions as determined by your doctor.

Nystatin Cream is a topical antifungal and barrier cream combination. The antifungal works by killing sensitive fungi. The cream works by providing a protective barrier to prevent skin irritation.

Do NOT use Nystatin Cream if:

• you are allergic to any ingredient in Nystatin Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nystatin Cream:

Some medical conditions may interact with Nystatin Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Nystatin Cream. However, no specific interactions with Nystatin Cream are known at this time.

Ask your health care provider if Nystatin Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nystatin Cream:

Use Nystatin Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gently cleanse the diaper area with very mild soap and lukewarm water before you apply Nystatin Cream. Pat the area dry with a soft towel.


• Apply enough medicine to cover the affected area. Rub in gently.


• Wash your hands immediately after using Nystatin Cream.


• Use the protective barrier cream as directed by your doctor.


• To clear up the infection completely, use Nystatin Cream for the full course of treatment. Keep using it even if the condition improves within a few days.


• If you miss a dose of Nystatin Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nystatin Cream.

Important safety information:

• Nystatin Cream is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse immediately with cool water.


• Do not get Nystatin Cream inside the vagina.


• Be sure to use Nystatin Cream for the full course of treatment. If you do not, the medicine may not clear up the infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin Cream while you are pregnant. It is not known if Nystatin Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Nystatin Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Nystatin Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild burning or itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent burning, irritation, itching, pain, or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Nystatin Cream:

Store Nystatin Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Nystatin Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Nystatin Cream, please talk with your doctor, pharmacist, or other health care provider.


• Nystatin Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nystatin Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nystatin resources

• Nystatin Use in Pregnancy & Breastfeeding
• Nystatin Support Group
• 6 Reviews for Nystatin - Add your own review/rating

Compare Nystatin with other medications

• Cutaneous Candidiasis
• Vaginal Yeast Infection

Nystatin Powder

Pronunciation: nye-STAT-in
Generic Name: Nystatin
Brand Name: Nystop

Nystatin Powder is used for:

Treating certain fungal infections. It may also be used for other conditions as determined by your doctor.

Nystatin Powder is an antifungal. It works by killing sensitive fungi.

Do NOT use Nystatin Powder if:

• you are allergic to any ingredient in Nystatin Powder

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nystatin Powder:

Some medical conditions may interact with Nystatin Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Nystatin Powder. However, no specific interactions with Nystatin Powder are known at this time.

Ask your health care provider if Nystatin Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nystatin Powder:

Use Nystatin Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clean the affected area with soap and water and dry thoroughly. Sprinkle enough powder to cover the affected area.


• If Nystatin Powder is used on the feet, sprinkle Nystatin Powder freely on the feet and in shoes and socks.


• Do not cover with a bandage or dressing unless directed otherwise by your doctor.


• Wash your hands immediately after using Nystatin Powder.


• To clear up your infection completely, use Nystatin Powder for the full course of treatment. Keep using it even if you feel better in a few days.


• Nystatin Powder works best if it is used at the same times each day.


• If you miss a dose of Nystatin Powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nystatin Powder.

Important safety information:

• Nystatin Powder is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse them right away with cool tap water.


• Be sure to use Nystatin Powder for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin Powder while you are pregnant. It is not known if Nystatin Powder is found in breast milk. If you are or will be breast-feeding while you use Nystatin Powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Nystatin Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Nystatin Powder. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, pain, or irritation of the affected area.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Nystatin Powder may be harmful if swallowed.

Proper storage of Nystatin Powder:

Store Nystatin Powder at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nystatin Powder out of the reach of children and away from pets.

General information:

• If you have any questions about Nystatin Powder, please talk with your doctor, pharmacist, or other health care provider.


• Nystatin Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nystatin Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nystatin resources

• Nystatin Use in Pregnancy & Breastfeeding
• Nystatin Support Group
• 6 Reviews for Nystatin - Add your own review/rating

Compare Nystatin with other medications

• Cutaneous Candidiasis
• Vaginal Yeast Infection

Norel LA Sustained-Release Tablets

Pronunciation: kar-bi-NOX-a-meen/fen-ill-EFF-rin
Generic Name: Carbinoxamine/Phenylephrine
Brand Name: Norel LA

Norel LA Sustained-Release Tablets are used for:

Relieving nasal symptoms (eg, congestion, runny nose, sneezing) and cough associated with allergies or the common cold.

Norel LA Sustained-Release Tablets are an antihistamine and decongestant combination. It works by blocking the action of histamine and reducing the symptoms of an allergic reaction. It also relieves nasal congestion by causing vasoconstriction and shrinkage of the nasal mucous membranes and promoting drainage.

Do NOT use Norel LA Sustained-Release Tablets if:

• you are allergic to any ingredient in Norel LA Sustained-Release Tablets


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or other severe heart problems


• you are taking sodium oxybate (GHB) or droxidopa, or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Norel LA Sustained-Release Tablets:

Some medical conditions may interact with Norel LA Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of high blood pressure, diabetes, increased pressure in the eye (glaucoma), an enlarged prostate or other prostate problems, asthma, heart problems (eg, ischemic heart disease, irregular heartbeat), blood vessel problems, stomach or urinary blockage, adrenal gland problems, seizures, stroke, trouble urinating, trouble sleeping, or an overactive thyroid

Some MEDICINES MAY INTERACT with Norel LA Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Norel LA Sustained-Release Tablets's side effects


• Benzodiazepines (eg, diazepam), bromocriptine, hydantoins (eg, phenytoin), or sodium oxybate (GHB) because the risk of their side effects may be increased by Norel LA Sustained-Release Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Norel LA Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norel LA Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Norel LA Sustained-Release Tablets:

Use Norel LA Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Norel LA Sustained-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Norel LA Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Norel LA Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of Norel LA Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Norel LA Sustained-Release Tablets.

Important safety information:

• Norel LA Sustained-Release Tablets may cause drowsiness, dizziness, or changes in vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Norel LA Sustained-Release Tablets. Using Norel LA Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Norel LA Sustained-Release Tablets. Norel LA Sustained-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Do not exceed the recommended dose or use Norel LA Sustained-Release Tablets for longer than prescribed without checking with your doctor.


• Do not use Norel LA Sustained-Release Tablets for persistent or chronic cough, such as a cough that occurs with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus, unless directed by your doctor.


• If you are scheduled for allergy skin testing, do not take Norel LA Sustained-Release Tablets for several days before the test because it may decrease your response to the skin tests.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Norel LA Sustained-Release Tablets.


• Do not take diet or appetite control medicines while you are taking Norel LA Sustained-Release Tablets without checking with your doctor.


• Norel LA Sustained-Release Tablets contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Use Norel LA Sustained-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially sleeplessness.


• Use Norel LA Sustained-Release Tablets with caution in CHILDREN because they may be more sensitive to its effects, especially drowsiness and excitability.


• Use Norel LA Sustained-Release Tablets with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Norel LA Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Norel LA Sustained-Release Tablets during pregnancy. Norel LA Sustained-Release Tablets may cause harm to the fetus if taken during late pregnancy. It is unknown if Norel LA Sustained-Release Tablets are excreted in breast milk. Do not breast-feed while using Norel LA Sustained-Release Tablets.

Possible side effects of Norel LA Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; excitability; headache; heartburn; nausea; nervousness; restlessness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; double vision; fast or irregular heartbeat; fever; frequent or painful urination; hallucinations; paleness; seizures; severe nervousness, anxiety, or excitability; severe or persistent headache or dizziness; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Norel LA side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; decreased mental alertness; enlarged pupils; fast, slow, or irregular heartbeat; flushing or pale skin; hallucinations; increased thirst or urination; loss of coordination; one-sided weakness; seizures; severe or persistent drowsiness, dizziness, or vomiting; speech or vision problems; tremors; trouble breathing.

Proper storage of Norel LA Sustained-Release Tablets:

Store Norel LA Sustained-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Norel LA Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Norel LA Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Norel LA Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Norel LA Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Norel LA resources

• Norel LA Side Effects (in more detail)
• Norel LA Use in Pregnancy & Breastfeeding
• Norel LA Drug Interactions
• Norel LA Support Group
• 0 Reviews for Norel LA - Add your own review/rating

Compare Norel LA with other medications

• Cold Symptoms
• Hay Fever

Novo-Hydrocort Cream Topical application

Generic Name: hydrocortisone butyrate (Topical application route)

hye-droe-KOR-ti-sone BUE-ti-rate

Commonly used brand name(s)

In the U.S.

• Locoid


• Locoid Lipocream

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Ointment


• Lotion


• Cream


• Solution

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Novo-Hydrocort Cream

Hydrocortisone butyrate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Novo-Hydrocort Cream

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in children 3 months of age or older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone butyrate

This section provides information on the proper use of a number of products that contain hydrocortisone butyrate. It may not be specific to Novo-Hydrocort Cream. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical cream or lotion on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 4 weeks.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For atopic dermatitis:
  
  • For topical dosage forms (cream and lotion):
    
    • Children 3 months to 18 years of age—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
    
    
  
  

• For redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream and ointment):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  

• For seborrheic dermatitis:
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Novo-Hydrocort Cream

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Novo-Hydrocort Cream Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Burning sensation of skin


• flushing or redness of skin


• itching skin


• red, scaling, or crusted skin


• scaly rash


• skin irritation


• unusually warm skin

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acne or pimples


• lightening of normal skin color

Incidence not known

• Burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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• Novo-Hydrocort Cream Topical application Drug Interactions
• Novo-Hydrocort Cream Topical application Support Group
• 15 Reviews for Novo-Hydrocort Topical application - Add your own review/rating

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• Seborrheic Dermatitis
• Skin Rash
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Novacort

Pronunciation: hye-droe-KOR-ti-sone/pra-MOX-een/AL-oh
Generic Name: Hydrocortisone/Pramoxine with Aloe
Brand Name: Novacort

Novacort is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.

Novacort is a combination topical corticosteroid and local anesthetic. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not clearly understood. It also decreases pain in the affected area.

Do NOT use Novacort if:

• you are allergic to any ingredient in Novacort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Novacort:

Some medical conditions may interact with Novacort. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis (TB), chickenpox, or shingles; or have had a positive TB test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Novacort. Because little, if any, of Novacort is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Novacort may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Novacort:

Use Novacort as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Novacort, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• If you miss a dose of Novacort, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Novacort.

Important safety information:

• Novacort is for external use only. Do not get Novacort in your eyes. If contact is made with the eyes, flush them immediately with tap water.


• If Novacort is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Check with your doctor before having vaccinations while using Novacort.


• Do not use Novacort for other skin conditions at a later time.


• Novacort has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Novacort.


• Serious side effects may occur if too much of Novacort is absorbed through the skin. This may be more likely to occur if you use Novacort over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Novacort. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Novacort while you are pregnant. It is not known if Novacort is found in breast milk after topical use. If you are or will be breast-feeding while you use Novacort, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Novacort:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Novacort; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Novacort side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Novacort:

Store Novacort at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Novacort out of the reach of children and away from pets.

General information:

• If you have any questions about Novacort, please talk with your doctor, pharmacist, or other health care provider.


• Novacort is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Novacort. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• Novacort Side Effects (in more detail)
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Nystop

nystatin

Dosage Form: powder
Nystop®

Nystatin Topical

Powder USP

For topical use only.

Not for ophthalmic use.

Nystop Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula:

Nystatin Topical Powder USP is for dermatologic use.

Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.

Nystop - Clinical Pharmacology

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C, tropicalis, C. guillier mondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and Usage for Nystop

Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.

Contraindications

Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Precautions

General

Nystatin Topical Powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

INFORMATION FOR THE PATIENT

Patients using this medication should receive the following information and instructions:

1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.


2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.


3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy:

Teratogenic Effects

Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General.)

Nystop Dosage and Administration

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older):

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

How is Nystop Supplied

Nystop® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles.

(NDC 0574-2008-15)

(NDC 0574-2008-30)

(NDC 0574-2008-02)

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C;104°F).

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(10-07)

PRINCIPAL DISPLAY PANEL- 15 grams label

Nystop®

Nystatin Topical Powder, USP

NDC 0574-2008-15

100,000 USP UNITS PER GRAM

Rx ONLY

USUAL DOSAGE: Apply to affected

area 2 or 3 times daily.

STORAGE: Store at controlled room

temperature 15°-30°C (59°-86°F);

avoid excessive heat (40°C; 104°F).

NET WEIGHT 15 GRAMS

Paddock

Laboratories, Inc.

Nystop  nystatin  powder

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-2008 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (Nystatin) Nystatin 100000 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength Talc

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-2008-15 15 g In 1 BOTTLE, PLASTIC None 2 0574-2008-30 30 g In 1 BOTTLE, PLASTIC None 3 0574-2008-02 60 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064118	08/16/1996

Labeler - Paddock Laboratories, Inc. (086116803)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, Inc.		086116803	MANUFACTURE

Revised: 08/2010Paddock Laboratories, Inc.

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