Label: IBUPROFEN  - ibuprofen tablet, coated IBUPROFEN - ibuprofen tablet, coated 

  • NDC Code(s): 52605-114-01, 52605-114-10, 52605-117-01
  • Packager: Polygen Pharmaceuticals LLC
  • 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 06/13

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

  • Active ingredient(s)


    Ibuprofen 200 mg (NSAID)*

     * nonsteroidal anti-inflammatory drug


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  • Purpose


    Pain reliever/Fever reducer


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  • Use(s)

    temporarily relieves minor aches and pain due to:

    • backache
    • headache
    • menstrual cramps
    • minor pain of arthritis
    • muscular aches
    • the common cold
    • toothache
    • temporarily reduces fever
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  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

    Symptoms may include: 

    • asthma (wheezing)
    • blisters
    • facial swelling
    • hives
    • rash
    • shock
    • skin reddening

    If an allergic reaction occurs, stop use and seek medical help right away.


    Stomach bleeding warning:
    This product contains an NSAID, which may cause 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the more or for a longer time than directed
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  • 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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  • Ask a doctor before use if

    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a history of stomach problems such as heartburn
    • the stomach bleeding warning applies to you
    • you have high blood pressure, heart disease , kidney disease, liver cirrhosis  
    • you are taking  a diuretic
    • you have asthma
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  • 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 other drug
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  • 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
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  • Stop use and ask doctor if

    • you experience any of the following 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 occur

    Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

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  • Pregnancy/Breastfeeding


    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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  • Keep out of reach of children


    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


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  • Directions


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

    •  do not use if seal under cap is broken or missing
    • see end panel for lot number and expiration date


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  • Inactive ingredient


    colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

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  • Storage

    • store between 20-25 °C (68-77 ° F).
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  • Questions


    1-888-291-7337


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  • Principal Display Panel


    CARTON LABEL PDP

     

    NDC: 52605-114-01

     

    Compare to the active ingredient in Advil®

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER (NSAID)

     

    100 COATED TABLETS

     

    SEE NEW WARNINGS INFORMATION
     


    Ibuprofen


    BOTTLE LABEL PDP

    NDC: 52605-114-01

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER(NSAID)

     

    100 COATED TABLETS

     

    SEE NEW WARNINGS INFORMATION



    ibu200tabbottlab


    CARTON LABEL PDP

     

    NDC: 52605-117-01

     

    Compare to the active ingredient in Advil®

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER (NSAID)

     

    100 COATED CAPLETS

     

    SEE NEW WARNINGS INFORMATION



    ibucarton100






    BOTTLE LABEL PDP

    NDC: 52605-117-01

     

    IBUPROFEN TABLETS, USP 200 mg

    PAIN RELIEVER/ FEVER REDUCER(NSAID)

     

    100 COATED CAPLETS

     

    SEE NEW WARNINGS INFORMATION



    ibubott100




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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52605-114
    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
    CROSCARMELLOSE SODIUM  
    COLLOIDAL SILICON DIOXIDE  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    TALC  
    TITANIUM DIOXIDE  
    STARCH, CORN  
    POLYVINYL ALCOHOL  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 114
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52605-114-01 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:52605-114-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091239 06/05/2012
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52605-117
    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
    CROSCARMELLOSE SODIUM  
    COLLOIDAL SILICON DIOXIDE  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    TALC  
    TITANIUM DIOXIDE  
    STARCH, CORN  
    POLYVINYL ALCOHOL  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code 117
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52605-117-01 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 ANDA091239 06/05/2012
    Labeler - Polygen Pharmaceuticals LLC (962415720)
    Registrant - Polygen Pharmaceuticals LLC (962415720)
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Limited 925822975 MANUFACTURE(52605-117)
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