Nabumetone (Page 6 of 6)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAlDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG)”.

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

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
(click image for full-size original)

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

Get emergency help if you experience these symptoms
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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 Generics Inc., USA
Mahwah, NJ 07430
Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444
label500
(click image for full-size original)

label750
(click image for full-size original)

label500label750
NABUMETONE
nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-650(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 GLYCOL
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:52959-650-00 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:52959-650-14 14 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:52959-650-20 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:52959-650-28 28 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:52959-650-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:52959-650-40 40 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
7 NDC:52959-650-42 42 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
8 NDC:52959-650-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
9 NDC:52959-650-90 90 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
NABUMETONE
nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-656(NDC:68462-359)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NABUMETONE (NABUMETONE) NABUMETONE 750 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (beige) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code IG;258
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-656-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:52959-656-02 120 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:52959-656-20 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:52959-656-28 28 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:52959-656-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
6 NDC:52959-656-40 40 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
7 NDC:52959-656-42 42 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
8 NDC:52959-656-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
9 NDC:52959-656-90 90 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 — H.J. Harkins Company, Inc. (147681894)
Registrant — Glenmark Generics Inc., USA (835917282)
Establishment
Name Address ID/FEI Operations
Invagen Pharmaceuticals Inc. 165104469 ANALYSIS, MANUFACTURE

Revised: 12/2011 H.J. Harkins Company, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.