Label: CHILDRENS IBUPROFEN- ibuprofen suspension 

  • Label RSS
  • 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 01/13

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

  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Ibuprofen 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
    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 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.

    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 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

    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

    give 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

    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 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. (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
    wash dosage cup after each use

    Dosing Chart

    Weight (lbs)

    Age (yrs)

    Dose (teaspoonful 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

    1 1/2 tsp or 7.5 mL

    48-59 lbs

    6-8 years

    2 tsp or 10 mL

    60-71 lbs

    9-10 years

    2 1/2 tsp or 12.5 mL

    72-95 lbs

    11 years

    3 tsp or 15 mL

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  • Other information

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

    anhydrous citric acid, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial bubblegum flavors, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient of Children’s Motrin® Bubble Gum Flavor

    for ages 2 to 11

    children’s

    ibuprofen oral suspension

    100 mg per 5 mL (teaspoonful)

    pain reliever / fever reducer

    (NSAID)

    lasts up to 8 hours

    alcohol free

    gluten free

    bubble gum flavored

    Children's Ibuprofen Oral Suspension Carton
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0166
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    FD&C RED NO. 40  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    HYPROMELLOSES  
    POLYSORBATE 80  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    XANTHAN GUM  
    Product Characteristics
    Color PINK (light) Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0166-4 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074937 05/10/2002
    Labeler - Rite Aid Corporation (014578892)
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