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Health Sense Infants Ibuprofen (Dolgencorp Inc)

Available Formats

Dosage Form Package Information Links
SUSPENSION 1 BOTTLE in 1 CARTON (55910-057-05) > 15 mL in 1 BOTTLE Label Information

Complete Health Sense Infants Ibuprofen Information

  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purpose

    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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 the child has
    • problems or serious side effects from taking pain relievers or fever reducers
    • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
    • ulcers
    • bleeding problems
    • not been drinking fluids
    • lost a lot of fluid due to vomiting or diarrhea
    • high blood pressure
    • heart or kidney disease
    • taken a diuretic

    Ask a doctor or pharmacist before use if the child is
    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • 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
    • long term continuous use may increase the risk of heart attack or stroke

    Stop use and ask a doctor if
    • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
    • stomach pain or upset gets worse or lasts
    • 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.


  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • do not give longer than 10 days, unless directed by a doctor (see Warnings)
    • shake well before using
    • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
    • measure with 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

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

  • Inactive ingredients

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


  • Questions or comments?

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  • Principal Display Panel

     Compare to active ingredient of Motrin® Infants' Drops

    Concentrated

    For Ages 6 mos.-23 mos.

    Infants' Ibuprofen Oral Suspension

    50 mg per 1.25 mL

    Pain Reliever/Fever Reducer (NSAID)

    Lasts up to 8 hours

    Alcohol Free

    Use Only With Enclosed Syringe

    Berry Flavor

    Product Carton

    Product Carton

    Product Label

    Product Label


  • INGREDIENTS AND APPEARANCE
    HEALTH SENSE INFANTS IBUPROFEN  ORAL SUSPENSION
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-057
    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
    Product Characteristics
    Color PINK (light) Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-057-05 1 in 1 CARTON
    1 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075217 06/08/2009
    Labeler - Dolgencorp Inc (068331990)