Label: MOTRIN- ibuprofen 800mg tablet, film coated

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

Drug Label Information

Updated September 7, 2021

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

  • Medication Guide Section

    SPL MEDGUIDE

    Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    (See the end of this Medication Guide for a list of prescription NSAID medicines.)

    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.

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

    Manufactured by:

    Granules India Limited

    Hyderabad-500 081, India

    MADE IN INDIA

    Distributed by:

    Ascend Laboratories, LLC

    Parsippany, NJ 07054

    Toll-Free No.: 1-877-272-7901

    Issued: October 2016

    For more information, please call to 1-877-770-3183.

    Rev. May/2019

  • Indications and Usage

    INDICATIONS AND USAGE

    Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. 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.

  • Adverse Reactions Section

    ADVERSE REACTIONS

    The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%.

    In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin or indomethacin-treated patients.

    Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.

    Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been established.

    Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table.



    Incidence Greater than 1%(but less than 3%)
    Probable Causal Relationship
    Precise Incidence Unknown
    (but less than 1%)
    Probable Causal Relationship**
    Precise Incidence Unknown
    (but less than 1%)
    Causal Relationship Unknown**
    GASTROINTESTINAL
    Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence)
    Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis

    CENTRAL NERVOUS SYSTEM
    Dizziness*, headache, nervousness
    Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS)
    Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri
    DERMATOLOGIC
    Rash*, (including maculopapular type), pruritus
    Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia
    Toxic epidermal necrolysis, photoallergic skin reactions

    SPECIAL SENSES
    Tinnitus
    Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and /or changes in color vision) (see PRECAUTIONS)
    Conjunctivitis, diplopia, optic neuritis, cataracts

    HEMATOLOGIC
    Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS)
    Bleeding episodes (e.g., epistaxis, menorrhagia)

    METABOLIC/ENDOCRINE
    Decreased appetite

    Gynecomastia, hypoglycemic reaction, acidosis
    CARDIOVASCULAR
    Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS)
    Congestive heart failure in patients with marginal cardiac function, elevate blood pressure, palpitations
    Arrhythmias (sinus tachycardia, sinus bradycardia)

    ALLERGIC
    Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS)
    Serum sickness, lupus erythematosus syndrome. Henoch-Schonlein vasculitis, angioedema
    RENAL
    Acute renal failure (see PRECAUTIONS), decreased creatinine clearance, poliuria, azotemia, cystitis, hematuria
    Renal papillary necrosis

    MISCELLANEOUS
    Dry eyes and mouth, gingival ulcer, rhinitis

    *Reactions occurring in 3% to 9% of patients treated with ibuprofen. (Those reactions occurring in less than 3% of the patients are unmarked).

    **Reactions are classified under “Probable Causal Relationship (PCR)” if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under “CausalRelationship Unknown” if seven or more events have been reported but the criteria for PCR have not been met

  • Principal Display Panel

    Ibuprofen 800mg

  • INGREDIENTS AND APPEARANCE
    MOTRIN 
    ibuprofen 800mg tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0046(NDC:67877-321)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code I;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0046-360 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09162512/21/2015
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0046)