Nabumetone (Page 6 of 6)

What are Non-Steroidal Anti-Inflammatory Drugs (NSAlDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAlDs)?

Side Effects Table
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Get emergency help right away if you have any of the following symptoms:

Get emergency help if you experience these symptoms
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Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

Stop NSAID if you experience these symptoms
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These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAlDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding inthe brain,stomach,and intestines. Aspirin can also cause ulcers in the stomach and intestines.

• Some of these NSAID medicines are sold in lower doses without a prescription (over-the- counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription:

NSAID medications that need a prescription
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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rx only

Manufactured by:

INVAGEN Pharmaceuticals, Inc
Hauppauge, NY 11788

Manufactured for:

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkgenerics.com

May 2009

Principal Display Panel

NDC 66336-0316-XX

NDC 66336-0316-XX
(click image for full-size original)
NABUMETONE
nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66336-316(NDC:68462-358)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NABUMETONE (NABUMETONE) NABUMETONE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9mm
Flavor Imprint Code IG;257
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66336-316-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078671 03/01/2008
Labeler — Dispensing Solutions, Inc. (066070785)
Registrant — PSS World Medical, Inc. (101822682)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (66336-316), repack (66336-316)

Revised: 07/2013 Dispensing Solutions, Inc.

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