Label: MOTRIN- ibuprofen 800mg tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 12, 2021

If you are a consumer or patient please visit this version.

  • Medication Guide Section

    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-FDA1088.

    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, go to www.amneal.com or call 1-877-835-5472.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured by:

    Amneal Pharmaceuticals Pvt. Ltd.

    Oral Solid Dosage Unit

    Ahmedabad 382213, INDIA

    Distributed by:
    Amneal Pharmaceuticals LLC

    Bridgewater, NJ 08807

    Rev. 06-2020-03

  • Indications and Usage Section

    INDICATIONS AND USAGE

    Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS].

    Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

    Ibuprofen Tablets are indicated for relief of mild to moderate pain.

    Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea.

    Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in children have not been conducted.

  • Contraindications Section

    CONTRAINDICATIONS

    Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen.

    Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

    Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS, ANAPHYLACTOID REACTIONS, and PRECAUTIONS, PREEXISTING ASTHMA].

    In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS].

  • Principal Display Panel

    Ibuprofen 800mg

  • INGREDIENTS AND APPEARANCE
    MOTRIN 
    ibuprofen 800mg tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0047(NDC:65162-466)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code IP;466
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0047-5100 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07855811/23/2009
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0047)