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Ibuprofen (Genuine First Aid LLC)

Available Formats

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TABLET 2 TABLET in 1 PACKET (52124-0009-1) Label Information

Complete Ibuprofen Information

  • Active Ingredient (in each tablet)

    Ibuprofen USP (NSAID*) 200mg
    *nonsteroidal anti-inflammatory drug


  • Purpose

    Pain reliever/fever reducer


  • Uses


    temporarily relieves minor aches and pains due to:

    the common cold

    headache

    toothache

    muscular aches

    backache

    minor pain of arthritis

    menstrual cramps temporarily reduces fever


  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed


  • DO NOT USE


    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.


  • ASK DOCTOR

    Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic


  • Ask a doctor before use if you are:

    taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug


  • When using this product

    take with food or milk if stomach upset occurs


  • Stop use and ask a doctor if

    you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.

    Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.


  • Other information

    Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets


  • Inactive Ingredients

    cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.


  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Cleveland Str Suite 400, Clearwater, FL 33755


  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN 2 Tablets


  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN   2 Tablets


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    Product Characteristics
    Color white (White) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;352
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0009-1 2 in 1 PACKET; Type 0: Not a Combination Product 02/17/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075010 02/17/2010
    Labeler - Genuine First Aid LLC (619609857)