RELAFEN- nabumetone tablet

RELAFEN by

Drug Labeling and Warnings

RELAFEN by is a Prescription medication manufactured, distributed, or labeled by BLUCREST PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Incidence < 1% - Probably Causally Related2

Gastrointestinal

Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.

Central Nervous System

Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.

Dermatologic

Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Cardiovascular

Vasculitis.

Metabolic

Weight gain.

Respiratory

Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.

Genitourinary

Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure.

Special Senses

Abnormal vision.

Hematologic/Lymphatic

Thrombocytopenia.

Hypersensitivity

Anaphylactoid reaction, anaphylaxis, angioneurotic edema.


  • 2 Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.
  • Incidence < 1% - Causal Relationship Unknown

    Gastrointestinal

    Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.

    Central Nervous System

    Nightmares.

    Dermatologic

    Acne, alopecia.

    Cardiovascular

    Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.

    Respiratory

    Asthma, cough.

    Genitourinary

    Dysuria, hematuria, impotence, renal stones.

    Special Senses

    Taste disorder.

    Body as a Whole

    Fever, chills.

    Hematologic/Lymphatic

    Anemia, leukopenia, granulocytopenia.

    Metabolic/Nutritional

    Hyperglycemia, hypokalemia, weight loss.

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

  • OVERDOSAGE

    Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

    Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

    There have been overdoses of up to 25 grams of nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

  • DOSAGE AND ADMINISTRATION

    Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

    After observing the response to initial therapy with nabumetone tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

    Osteoarthritis and Rheumatoid Arthritis

    The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone tablets can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment (see WARNINGS). Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients' requirements.

  • HOW SUPPLIED

    RELAFEN Nabumetone tablets USP, 500 mg are white, coated, modified capsule-shaped tablets, debossed with "HT" on one side and "500" on the other. They are available in bottles of: 30 tablets - NDC: 73684-100-30.

    RELAFEN Nabumetone tablets USP, 750 mg are white, coated, modified capsule-shaped tablets, debossed with "HT" on one side and "750" on the other. They are available in bottles of: 30 tablets - NDC: 73684-101-30.

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Blucrest Pharmaceuticals, LLC
    Hazlet, NJ 07730
    www.blucrestpharma.com

    Rev 03/2020

  • MEDICATION GUIDE

    This Medication Guide has been approved by the U.S. Food and Drug Administration.Rev. 03/2020
    Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
    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
    NSAIDs should only be used:
    • exactly as prescribed
    • at the lowest dose possible for your treatment
    • for the shortest time needed
    What are NSAIDs?
    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.
    Manufactured for: Blucrest Pharmaceuticals, LLC. Hazlet, NJ 07730.
    For further information please visit: www.blucrestpharma.com
  • PRINCIPAL DISPLAY PANEL - 750 mg Tablet Bottle Label

    NDC: 73684-101-30

    RELAFEN®
    (Nabumetone Tablets, USP)

    750 mg

    PHARMACIST: PLEASE DISPENSE WITH
    MEDICATION GUIDE PROVIDED SEPARATELY

    30 Tablets

    BluCrest
    PHARMACEUTICALS LLC.

    Rx Only

    Principal Display Panel - 750 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

    NDC: 73684-100-30

    RELAFEN®
    (Nabumetone Tablets, USP)

    500 mg

    PHARMACIST: PLEASE DISPENSE WITH
    MEDICATION GUIDE PROVIDED SEPARATELY

    30 Tablets

    BluCrest
    PHARMACEUTICALS LLC.

    Rx Only

    Principal Display Panel - 500 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    RELAFEN 
    nabumetone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73684-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z) NABUMETONE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Hydroxypropyl Cellulose (90000 WAMW) (UNII: UKE75GEA7F)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code HT;750
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 73684-101-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20316606/01/2020
    RELAFEN 
    nabumetone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73684-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z) NABUMETONE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Hydroxypropyl Cellulose (90000 WAMW) (UNII: UKE75GEA7F)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code HT;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 73684-100-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20316606/01/2020
    Labeler - BLUCREST PHARMACEUTICALS LLC (117424533)

  • Trademark Results [RELAFEN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RELAFEN
    RELAFEN
    87702292 not registered Live/Pending
    Argent Development Group, LLC
    2017-11-29
    RELAFEN
    RELAFEN
    86251872 not registered Dead/Abandoned
    Argent Development Group, LLC
    2014-04-14
    RELAFEN
    RELAFEN
    73353073 1248125 Dead/Cancelled
    Beecham Inc.
    1982-03-04

    © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.