IBUPROFEN TABLET, FILM COATED [DOLGENCORP, LLC]

IBUPROFEN TABLET, FILM COATED [DOLGENCORP, LLC]
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NDC 55910-392-12
Set ID d00bbec7-d507-b571-4e16-5c72f726ab87
Category HUMAN OTC DRUG LABEL
Packager DOLGENCORP, LLC
Generic Name
Product Class
Product Number
Application Number ANDA075139
  • DRUG FACTS

  • ACTIVE INGREDIENT

    (in each orange caplet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USES

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

    • 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

    • stomach bleeding warning applies to you 
    • you have problems or serious side effects from taking pain relievers or fever reducers 
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma 
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition 
    • 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
    • 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
      • 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

    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.

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

  • DIRECTIONS

     

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see WARNINGS )
    • 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
  • OTHER INFORMATION

    • store at controlled room temperature 
    • avoid excessive heat above 40°C (104°F)
    • see end flap or expiration date and lot number
  • INACTIVE INGREDIENTS

     

    carnauba wax, cellulose, corn starch, FD&C yellow #6, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodiumstarch glycolate, stearic acid, titanium dioxide

    Questions or comments?

    call 1-800-426-9391

  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    DG

    health

    Compare to active ingredient of Motrin® IB†

    Ibuprofen

    Tablets 200 mg

    Pain Reliever/Fever Refucer (NSAID)

    SEE NEW WARNINGS INFORMATION

    100

    Coated Tablets

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844 REV1209B39212

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    Product Label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-392
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Powdered Cellulose (UNII: SMD1X3XO9M)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
    Hypromellose (UNII: 3NXW29V3WO)  
    Lactose (UNII: J2B2A4N98G)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Polydextrose (UNII: VH2XOU12IE)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;392
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-392-121 in 1 CARTON
    1100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07513903/02/1999
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    L.N.K. International, Inc.038154464MANUFACTURE

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