PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]

PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]
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NDC 52904-447-02
Set ID 87feec83-7b0a-41b5-972f-80592bab7c2d
Category HUMAN OTC DRUG LABEL
Packager Select Corporation
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • ACTIVE INGREDIENT

    Active Ingredients

    Ibuprofen USP 200 mg


  • PURPOSE

    Pain reliever/fever reducer, nonsteroidal anti-inflammatory drug

  • DOSAGE & ADMINISTRATION

    Directions: • do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: • 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: • ask a doctor

  • INDICATIONS & USAGE

    Uses • temporarily relieves minor aches and pains due to:• headache • muscular aches • minor pain of arthritis • toothache •backache •the common cold • menstrual cramps • temporarily reduces fever

  • WARNINGS

    Warnings: Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: •hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an 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 thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAID’s (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 • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • you have problems or serious side effects from taking pain relievers or fever reducers • the stomach bleeding warning applies to you • you have a history of stomach problems such as heartburn• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you have asthma • you are taking a diuretic Ask a doctor or pharmacist before use if you are • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • under a doctor’s care for any serious condition • taking any other drug When using this product • take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 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 • you have stomach pain that does not 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.

  • INACTIVE INGREDIENT

    Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, olyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

  • PRINCIPAL DISPLAY PANEL

    MM1

    Pain Ibuprofen packet

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-447
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (115) Size10mm
    FlavorImprint Code 115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-447-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123910/15/2012
    Labeler - Select Corporation (053805599)
    Registrant - Select Corporation (053805599)

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