Label: IBUPROFEN INFANTS- ibuprofen suspension 

  • NDC Code(s): 42507-057-05, 42507-057-10
  • Packager: HyVee 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 10/12

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

  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    temporarily:

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

    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 below. If possible, use weight to dose; otherwise use age.
    measure with the dosing device provided. Do not use with any other device.
    dispense liquid slowly into the child’s mouth, toward the inner cheek
    if needed, repeat dose every 6-8 hours
    do not use more than 4 times a day

    Dosing Chart

    Weight (lb)

    Age (mos)

    Dose (mL)

    under 6 mos

    ask a doctor

    12-17 lbs

    6-11 mos

    1.25 mL

    18-23 lbs

    12-23 mos

    1.875 mL

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  • Other information

    do not use if printed neckband is broken or missing
    store at 20-25°C (68-77°F)
    do not freeze
    see bottom of box for lot number and expiration date
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  • Inactive ingredients

    anhydrous citric acid, artificial flavor, butylparaben, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    See New Warnings Information

    Compare to Motrin® Infants' Drops Berry Flavor active ingredient

    CONCENTRATED DROPS

    For Ages 6 Mos. to 23 Mos.

    Infants' Ibuprofen

    Oral Suspension

    50 mg per 1.25 mL

    Pain Reliever/Fever Reducer (NSAID)

    Alcohol Free

    Berry Flavored Drops

    Lasts Up To 8 Hours

    No High Fructose Corn Syrup

    Use Only With Enclosed Syringe

    Infants' Ibuprofen Carton Image 1
    Infants' Ibuprofen Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  INFANTS
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-057
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 50 mg  in 1.25 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    BUTYLPARABEN  
    FD&C RED NO. 40  
    GLYCERIN  
    HYPROMELLOSES  
    POLYSORBATE 80  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    SUCROSE  
    XANTHAN GUM  
    Product Characteristics
    Color PINK (light) Score     
    Shape Size
    Flavor FRUIT (mixed) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-057-05 1 in 1 CARTON
    1 15 mL in 1 BOTTLE
    2 NDC:42507-057-10 1 in 1 CARTON
    2 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075217 09/03/2000
    Labeler - HyVee Inc (006925671)
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