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

  • Label RSS
  • 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

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 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 LABEL Item Code (Source) NDC:65162-356
    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
    FD&C BLUE NO. 1  
    GELATIN  
    POLYETHYLENE GLYCOL 400  
    WATER  
    POTASSIUM HYDROXIDE  
    SORBITOL  
    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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