Label: IBUPROFEN- ibuprofen capsule, coated

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

Drug Label Information

Updated 02/13

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

  • Active ingredient (in each brown caplet)

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

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  • Purpose

     Pain reliever/fever reducer

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  • 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
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  • 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:

    • have had stomach ulcers or bleeding problems
    • 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 a blood thinning (anticoagulant) or steroid drug
    • take more or for a longer time than directed
    • right before or after heart surgery
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    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

    • 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 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
    • 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
      • have bloody or black stools
      • vomit blood
      • 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 complication during delivery.

    Keep out of reach of children.

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

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  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adult and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
      • if pain or fever does not respond to 1 caplet, 2 caplets may be used
      • do not exceed 6 caplets in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
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  • Other information

    • store between 20º-25ºC (68º-77ºF)
    • avoid excessive heat 40ºC (104ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystallin cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium stach glycolate, stearic acid, titanium dioxide.

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  • Questions or comments?

    Call 1-800-426-9392
    8:30 AM-4:00 PM ET, Monday - Friday

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  • Principal Display Panel

    Compare to the active ingredient in Advil® Caplets†

    NDC 37808-922-13

    H-E-B®

    IBUPROFEN
    Tablets USP, 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    250 Coated Caplets**
    **Capsule-shaped tablets 

    Contains No Gluten

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Caplets.
    50844    ORG041129213

    MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

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

    HEB 44-292

    HEB 44-292

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-922
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code 44;292
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-922-13 1 in 1 CARTON
    1 250 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075010 05/24/1988
    Labeler - H E B (007924756)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(37808-922)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(37808-922)
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