Label: IBUTAB - ibuprofen tablet 

  • Label RSS
  • NDC Code(s): 35418-750-02, 35418-750-67, 35418-750-68, 35418-750-69
  • Packager: Zee Medical Inc
  • 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 06/12

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

  • ACTIVE INGREDIENT

    Active Ingredient/Tablet Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Purpose-Pain Reliever/Fever Reducer

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  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves minor aches and pains due to:
    ■ headache ■ the common cold ■ muscular aches
    ■ backache ■ toothache ■ minor pain of arthritis
    ■ menstrual cramps
    ■ temporarily reduces fever

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  • DOSAGE & ADMINISTRATION

    Directions
    ■ do not take more than directed
    ■ the smallest effective dose should be used
    ■ do not take longer than 10 days, unless directed by a doctor (see
    Warnings)
    ■ adults: 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
    ■ children under 12 years: ask a doctor Close
  • WARNINGS

    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
    ■ rash ■ skin reddening ■ 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
    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 problems or serious side effects from taking pain
    relievers or fever reducers
    ■ you have high blood pressure, heart disease, liver cirrhosis,
    kidney disease, or asthma
    ■ you are taking a diuretic
    Ask a doctor or pharmacist before use if you are
    ■ under a doctor's care for any serious condition
    ■ taking aspirin to prevent heart attack or stroke, because
    ibuprofen may decrease this benefit of aspirin
    ■ taking any other 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 ■ 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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  • 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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  • 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 right away.  
    Prompt medical attention is critical for adults as well as for  
    children even if you do not notice any signs or symptoms.

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  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax*, cellulose,
    croscarmellose sodium*, DC yellow 10*, FDC blue 2*, FDC
    red 40*, FDC yellow 6*, hydroxypropyl methylcellulose,
    magnesium stearate, maltodextrin*, polyethylene glycol*,
    polysorbate 80*, red iron oxide, silicon dioxide, sodium starch
    glycolate*, starch*, talc*, titanium dioxide, triacetin*
    *Contains one or more of these ingredients.

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  • PRINCIPAL DISPLAY PANEL

    Mm1Ibutab, 250 Box

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  • INGREDIENTS AND APPEARANCE
    IBUTAB 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-750
    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  
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    POLYETHYLENE GLYCOL 300  
    POLYSORBATE 80  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color brown (chocolate brown) Score no score
    Shape ROUND (IBU;200) Size 110mm
    Flavor Imprint Code IBU;200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-750-69 500 in 1 CARTON
    1 NDC:35418-750-67 125 in 1 CARTON
    1 NDC:35418-750-68 50 in 1 CARTON
    1 NDC:35418-750-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079129 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-750)
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