Label: IBUTAB - ibuprofen tablet

  • 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

Drug Label Information

Updated 06/12

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  • 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 Item Code (Source) NDC:35418-750
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    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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