Label: IBUPROFEN- ibuprofen capsule, coated

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

Drug Label Information

Updated 10/12

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

  • Active ingredient (in each orange 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
      • toothecahe
      • 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 a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinnks 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 a history of stomach problems, such as heartburn
    • you have asthma
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers 

    Ask a doctor or pharmacist before use if

    • 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 of 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
    • adults 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 excess heat 40ºC (104ºF)
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

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

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  • Questions or comments?

     Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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  • Principal Display Panel

    NDC 21130-291-08
    Compare to Motrin® IB active ingredient†

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

    SEE NEW WARNINGS INFORMATION

    100 CAPLETS**     **Capsule-shaped tablets

    SAFEWAY

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Motrin® IB.

    50844        REV0411C39312

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

    Safeway 44-393

    Safeway 44-393

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-393
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    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 ORANGE Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code 44;393
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-393-12 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075139 04/08/2002
    Labeler - Safeway (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-393)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-393)
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