Label: HELP I HAVE AN ACHING BODY- ibuprofen tablet

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

Drug Label Information

Updated March 5, 2013

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

  • ACTIVE INGREDIENT

    Active Ingredient..................................................Purpose
    (in each tablet)


    Ibuprofen 200 mg (NSAID)*.....................................Pain reliever/ Fever reducer

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Use

    Temporarily relieves minor aches and pains due to • common cold • headache
    • toothache • muscular aches • backache • minor pain of arthritis • 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:
    • shock • hives • facial swelling • asthma (wheezing) • rash • skin reddening • blisters 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 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 an NSAID (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.

    Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are the signs of stomach bleeding
    • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts
    more than 10 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear.

    Ask a doctor before use if you have • problems or serious side effects from taking pain relievers or fever reducers • stomach
    problems that last or come back, such as heartburn, upset stomach, or stomach pain • bleeding problems • ulcers • high blood
    pressure • taken a diuretic • heart or kidney disease • reached age 60 or older.

    Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or non prescription)
    • taking a blood thinning agent (anticoagulant) or steroid drug • taking any other drug • under a doctor’s care for any serious condition.


  • 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

  • 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. (1-800-222-1222)
  • 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.

  • DOSAGE & ADMINISTRATION


    When using this product
    • take with food or milk if stomach upset occurs • long term continuous use may increase the risk of a heart attack or stroke.

    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 yeas: ask a doctor • do not take more than directed
    • the smallest effective dose should be used

  • INDICATIONS & USAGE


    Directions
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)

    Other information
    • do not use if packet is torn, cut or opened
    • store at controlled room temperature 15-30°C (59-86°F) • avoid excessive heat and humidity
    • keep carton. They contain important information.
  • QUESTIONS



    Distributed by Help Remedies,
    57 W. 28th St. Fl. 4
    New York, NY 10001

    www.helpineedhelp.com

  • PRINCIPAL DISPLAY PANEL

    achingbodylabel

  • INACTIVE INGREDIENT

    Inactive ingredients

    colloidal silicon dioxide, croscar-mellose sodium, hydroxypropyl
    cellulose, hympromellose, micro-crystalline
    cellulose, pregelatinized starch, stearic acid,
    titanium dioxide.

  • INGREDIENTS AND APPEARANCE
    HELP I HAVE AN ACHING BODY 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-615
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size10mm
    FlavorImprint Code 44352
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49260-615-5050 in 1 BOTTLE
    2NDC:49260-615-1616 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07513907/01/2009
    Labeler - Help Remedies, Inc. (050359682)