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ibuprofen (HyVee Inc)

Available Formats

Dosage Form Package Information Links
SUSPENSION 1 BOTTLE in 1 CARTON (42507-057-10) > 30 mL in 1 BOTTLE Label Information
SUSPENSION 1 BOTTLE in 1 CARTON (42507-057-05) > 15 mL in 1 BOTTLE Label Information

Complete ibuprofen Information

  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purposes

    Pain reliever/fever reducer


  • 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

    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)


  • 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


  • Other information

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

  • Inactive ingredients

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


  • Questions or comments?

    1-800-719-9260


  • Principal Display Panel

    COMPARE TO the Active Ingredient of Motrin® Infants’ Drops

    For Ages 6 Mos. to 23 Mos.

    Infants’

    Ibuprofen Oral Suspension

    50 mg per 1.25 mL

    Pain Reliever / Fever Reducer (NSAID)

    Concentrated Drops

    Original Berry Flavor

    Lasts Up to 8 Hours

    No High Fructose Corn Syrup

    Use Only with Enclosed Syringe

    0.5 FL OZ (15 mL)

    Infants' Ibuprofen Oral Suspension Carton Image


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  INFANTS
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-057
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 50 mg  in 1.25 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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)