Label: IBUPROFEN- ibuprofen capsule, coated 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:21130-393
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM STEARATE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    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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