Label: CHILDRENS IBUPROFEN - ibuprofen suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 8, 2017

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

  • ACTIVE INGREDIENT

    (in each 5 mL = 1 teaspoon)

    Ibuprofen, USP 100 mg (NSAID)**

    **nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Pain reliever/fever reducer

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  • USES

    temporarily:

    • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
    • 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
    • shock
    • asthma (wheezing)
    • rash
    • skin reddening
    • blisters
    • facial swelling

    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 your 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

    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.

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  • 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
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  • ASK DOCTOR BEFORE USE IF

    • stomach bleeding warning applies to your child
    • child has a history of stomach problems, such as heartburn
    • child has problems or serious side effects from taking pain relievers or fever reducers
    • child has not been drinking fluids
    • child has lost a lot of fluid due to vomiting or diarrhea
    • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • child has asthma
    • child is taking a diuretic
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  • ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

    • under a doctor's care for any serious condition
    • 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 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
    • the child does not get any relief within the 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
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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

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • shake well before using
    • find right dose on chart.  If possible, use weight to dose; otherwise use age.
    • use only enclosed measuring cup
    • if needed, repeat dose every 6-8 hours
    • do not use more than 4 times a day
    • replace original bottle cap to maintain child resistance
    Dosing Chart
    Weight (lb) Age (yr) Dose (tsp or mL)
    under 2 years ask a doctor
    24 – 35 lbs 2 – 3 years 1 tsp or 5 mL
    36 – 47 lbs 4 – 5 years 1½ tsp or 7.5 mL
    48 – 59 lbs 6 – 8 years 2 tsp or 10 mL
    60 – 71 lbs 9 – 10 years 2½ tsp or 12.5 mL
    72 – 95 lbs 11 years 3 tsp or 15 mL

    Other information

    • each teaspoon contains: sodium 2 mg
    • do not use if printed neckband is broken or missing
    • store between 20 - 25°C (68 - 77°F)
    • see bottom panel for lot number and expiration date
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  • INACTIVE INGREDIENT

    Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

    Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

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  • QUESTIONS?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

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  • PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label

    Austin/Travis Co. Health & Human Services Dept.
    1000 Toyath St Austin, TX 78702 512-972-6206

    IBUPROFEN
    100MG/5ML
    SUSP.

    Date:

    Name:
    Dr.

    TAKE ___ ML BY MOUTH ___ TIMES A DAY.

    05/2018

    L606011

    IBUPROFEN 100MG/5ML ORAL SUSP. #120 NDC 76413-344-01

    Batch: 08301708
    Lot: L606011
    Exp: 05/2018
    ACTAVIS

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-344(NDC:0472-1255)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color ORANGE (red) Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76413-344-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2006
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074916 06/01/2006
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    Name Address ID/FEI Business Operations
    Central Texas Community Health Centers 079674019 REPACK(76413-344) , RELABEL(76413-344)
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