Nabumetone (Page 6 of 6)
HOW SUPPLIED
Nabumetone Tablets USP, 500 mg are available as white to off white, oval shaped, biconvex, film-coated tablets, debossed with “LU” on one side and “V01” on the other side.
They are supplied as follows:
NDC 68180-141-01 Bottles of 100’s
NDC 68180-141-03 Bottles of 1000’s
Nabumetone Tablets USP, 750 mg are available as white to off white, oval shaped, biconvex, film-coated tablets, debossed with “LU” on one side and “V02” on the other side.
They are supplied as follows:
NDC 68180-142-01 Bottles of 100’s
NDC 68180-142-03 Bottles of 1000’s
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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1 Throughout this package insert, the term NSAID refers to a non-aspirin non- steroidal anti-inflammatory drug.
2 Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked.
3 † Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Manufactured by:
Lupin Limited
Goa 403722
INDIA
August 7, 2015 ID#: 242328
For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
- Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
- with increasing doses of NSAIDs
- with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
- Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
- anytime during use
- without warning symptoms
- that may cause death
The risk of getting an ulcer or bleeding increases with:
- past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
- taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
- increasing doses of NSAIDs
- longer use of NSAIDs
- smoking
- drinking alcohol
- older age
- poor health
- advanced liver disease
- bleeding problems
- exactly as prescribed
- at the lowest dose possible for your treatment
- for the shortest time needed
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
- if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
- right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:
- have liver or kidney problems
- have high blood pressure
- have asthma
- are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
- are breastfeeding or plan to breast feed.
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
What are the possible side effects of NSAIDs?
NSAIDs can cause serious side effects, including:
See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
- new or worse high blood pressure
- heart failure
- liver problems including liver failure
- kidney problems including kidney failure
- low red blood cells (anemia)
- life-threatening skin reactions
- life threatening allergic reactions
- Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms:
- shortness of breath or trouble breathing
- chest pain
- weakness in one part or side of your body
- slurred speech
- swelling of the face or throat
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
- nausea
- more tired or weaker than usual
- diarrhea
- itching
- your skin or eyes look yellow
- indigestion or stomach pain
- flu-like symptoms
- vomit blood
- there is blood in your bowel movement or it is black and sticky like tar
- unusual weight gain
- skin rash or blisters with fever
- swelling of the arms, legs, hands and feet
If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about NSAIDs
- Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
- Some NSAIDs 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.
General information about the safe and effective use of NSAIDs
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
For more information about nabumetone tablets, call 1-800-399-2561 or go to www.lupinpharmaceuticals.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Manufactured by:
Lupin Limited
Goa 403722
INDIA
August 7, 2015 ID#: 242329
PRINCIPAL DISPLAY PANEL
NABUMETONE TABLETS USP
500 MG
Rx only
Bottle of 100 Tablets
NABUMETONE TABLETS USP
750 MG
Rx only
Bottle of 100 Tablets
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| Labeler — Lupin Pharmaceuticals, Inc. (089153071) |
| Registrant — LUPIN LIMITED (675923163) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LUPIN LIMITED | 677600414 | MANUFACTURE (68180-141), MANUFACTURE (68180-142) | |
Revised: 12/2019 Lupin Pharmaceuticals, Inc.
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