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PediaCare Infants (Medtech Products Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, WITH APPLICATOR in 1 CARTON (63029-900-01) > 30 mL in 1 BOTTLE, WITH APPLICATOR Label Information

Complete PediaCare Infants Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*


  • Purpose

    Pain reliever/Fever reducer

    * nonsteroidal anti-inflammatory drug


  • 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
    • shock
    • rash
    • asthma (wheezing)
    • skin reddening
    • 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 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 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
    • 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

    Stop use and ask a doctor if
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • child experiences any of the following sighs 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 does 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 to 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 to 17 lbs   6 to 11 mos   1.25 mL
      18 to 23 lbs   12 to 23 mos   1.875 mL

  • Other information

    • store between 20º to 25ºC (68º to 77ºF)
    • do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing
    • see bottom panel for lot number and expiration date

  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.


  • Questions or Comments?

    call 1-888-474-3099 Monday through Friday 8AM to 8PM EST or visit us at www.PediaCare.com


  • PRINCIPAL DISPLAY PANEL

    NEW! INFANTS 6-23 months
    PediaCare® we care for kidsTM
    PAIN RELIEVER
    FEVER REDUCER
    IB Ibuprofen
    Concentrated Oral Suspension, USP
    (NSAID) 50 mg/ 1.25mL
    Alcohol Free
    Dye-Free Berry FLAVOR
    Lasts up to 8 hours!
    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL NEW! INFANTS 6-23 months PediaCare® IB Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg/ 1.25mL Alcohol Free Dye-Free Berry FLAVOR 1 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    PEDIACARE INFANTS 
    ibuprofen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-900
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-900-01 1 in 1 CARTON 10/15/2011
    1 30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2 NDC:63029-900-05 1 in 1 CARTON 10/15/2011 08/31/2017
    2 15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079058 10/15/2011
    Labeler - Medtech Products Inc. (122715688)