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JUNIOR STRENGTH ADVIL (Pfizer Consumer Healthcare)

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TABLET, COATED 1 BOTTLE in 1 CARTON (0573-0175-11) > 24 TABLET, COATED in 1 BOTTLE Label Information

Complete JUNIOR STRENGTH ADVIL Information

  • DRUG FACTS


  • ACTIVE INGREDIENT (IN EACH TABLET)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • PURPOSE

    Fever reducer/Pain reliever


  • USES

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

  • 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if the child

    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • takes more or for a longer time than directed

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Sore throat warning:

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

    Do not use
    • if the child has 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 the child
    • child has problems or serious side effects from taking pain relievers or fever reducers
    • child has a history of stomach problems, such as heartburn
    • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • child has not been drinking fluids
    • child has lost a lot of fluid due to vomiting or diarrhea
    • child is taking a diuretic

    Ask a doctor or pharmacist before use if the child is
    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product
    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if
    • child experiences any of the following signs of stomach bleeding:
      • feels faint
      • vomits blood
      • has bloody or black stools
      • has stomach pain that does not get better
    • child has symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
    • child does not get any relief within first day (24 hours) of treatment
    • fever or pain gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.


  • DIRECTIONS

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • find right dose on chart below. If possible, use weight to dose; otherwise use age.
    • repeat dose every 6-8 hours, if needed
    • do not use more than 4 times a day
    Dosing Chart
    Weight (lb) Age (yr) Dose (tablets)
    under 48 lb under 6 yr ask a doctor
    48-71 lb 6-10 yr 2 tablets
    72-95 lb 11 yr 3 tablets

  • OTHER INFORMATION

    • one dose lasts 6-8 hours
    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
    • see side of box for lot number and expiration date

  • INACTIVE INGREDIENTS

    acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide


  • QUESTIONS OR COMMENTS?

    call toll free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional


  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

    Ages 6-11
    Junior Strength
    Advil
    ®
    Ibuprofen Tablets, 100 mg
    Pain Reliever/Fever Reducer (NSAID)

    24 Coated Tablets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton

    Junior Strength
    Advil
    ®

    Ibuprofen Tablets, 100 mg
    Pain Reliever/Fever Reducer (NSAID)

    Fever
    Aches & Pains

    Lasts Up To
    8
    Hours

    for ages 6-11 years

    24 COATED
    TABLETS

    PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton

  • INGREDIENTS AND APPEARANCE
    JUNIOR STRENGTH ADVIL 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0175
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BROWN (tan) Score no score
    Shape ROUND (round tablet) Size 8mm
    Flavor Imprint Code Advil;100
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0175-11 1 in 1 CARTON 06/21/2011
    1 24 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020267 06/21/2011
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0175) , LABEL(0573-0175) , MANUFACTURE(0573-0175) , PACK(0573-0175)