IBUPROFEN TABLET, FILM COATED [DOLGENCORP, LLC]

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IBUPROFEN TABLET, FILM COATED [DOLGENCORP, LLC]
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NDC 55910-932-59
Set ID 3b9fe17e-84bf-4e2c-aa21-20fb00c1fbfb
Category HUMAN OTC DRUG LABEL
Packager DOLGENCORP, LLC
Generic Name
Product Class
Product Number
Application Number ANDA075139
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  • Active ingredient (in each orange tablet)

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

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • facial swelling
    • asthma (wheezing)
    • rash
    • hives
    • skin reddening
    • blisters
    • shock

    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 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

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • right before or after heart surgery
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Ask a doctor before use if

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

    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

    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
    • you have symptoms of heart problems or stroke:
      • chest pain
      • weakness in one part or side of body
      • leg swelling
      • trouble breathing
      • slurred speech
    • 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 (1-800-222-1222) right away.

  • 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 
  • Other information

    • store between 20º-25ºC (68º-77ºF)
    • avoid excessive heat 40ºC (104ºF)
    • use by expiration date on package
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

  • Principal Display Panel

    Since 1903
    Rexall®

    Ibuprofen

    Ibuprofen Tablets USP,
    200 mg
    Pain Reliever/
    Fever Reducer
    (NSAID)

    275
    Tablets

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

    50844                  REV1116B39259
    Visit us at: Rexall.com or call 1-866-4-REXALL
    MANUFACTURED FOR DOLGENCORP, LLC
    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

    Rexall 44-329

    Rexall 44-329


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-932
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;392
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-932-59275 in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07513903/01/1999
    Labeler - DOLGENCORP, LLC (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(55910-932)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(55910-932)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(55910-932)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(55910-932)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(55910-932)
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