Label: IBUPROFEN PAIN RELIEVER/FEVER REDUCER- ibuprofen capsule, liquid filled

  • NDC Code(s): 65162-356-02, 65162-356-11, 65162-356-50, 65162-356-69
  • Packager: Amneal Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/12

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

  • OTC - ACTIVE INGREDIENT

    (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    * nonsteroidal anti-inflammatory drug

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  • OTC - PURPOSE

    Pain reliever/Fever reducer

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  • INDICATIONS AND USAGE

    • 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 a nonsteroidal anti-inflammatory drug (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
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  • OTC - DO NOT USE

    Do not use

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

    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
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  • OTC - ASK DOCTOR/PHARMACIST

    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
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  • OTC - WHEN USING

    When using this product

    • take with food or milk if upset stomach occurs
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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  • OTC - STOP USE

    Stop use and ask a doctor if

    • you experience any of the follwing 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
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  • OTC - PREGNANCY OR BREAST FEEDING

    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.

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  • OTC - KEEP OUT OF REACH OF CHILDREN

    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.

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  • DOSAGE AND ADMINISTRATION

    DIRECTIONS

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

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use.  Keep carton.
    • Store at 20º to 25ºC (68º to 77ºF)
    • avoid excessive heat above 40ºC (104ºF)
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  • INACTIVE INGREDIENT

    FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

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  • OTC – QUESTIONS OR COMMENTS?

    Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST

    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

    Do Not Use if printed foil under cap is broken or missing.

    Distributed by:  Amneal Pharmaceuticals

    Glasgow, KY  42141

    Rev. 03-2012

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  PAIN RELIEVER/FEVER REDUCER
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-356
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code A356
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65162-356-02 1 in 1 CARTON
    1 20 in 1 BOTTLE
    2 NDC:65162-356-69 1 in 1 CARTON
    2 80 in 1 BOTTLE
    3 NDC:65162-356-50 500 in 1 BOTTLE
    4 NDC:65162-356-11 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202300 03/29/2013
    Labeler - Amneal Pharmaceuticals (123797875)
    Registrant - Amneal Pharmaceuticals (123797875)
    Establishment
    Name Address ID/FEI Business Operations
    Amneal Pharmaceuticals 831227777 ANALYSIS(65162-356) , MANUFACTURE(65162-356) , LABEL(65162-356) , PACK(65162-356)
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