Home > Drugs A-Z > PediaCare Infants Fever Reducer Cherry

PediaCare Infants Fever Reducer Cherry (Blacksmith Brands, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, DROPPER in 1 BOX (52183-393-01) > 30 mL in 1 BOTTLE, DROPPER Label Information

Complete PediaCare Infants Fever Reducer Cherry Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    (in each 0.8 mL)

    Acetaminophen 80mg


  • Purpose

    Pain reliever/fever reducer


  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • flu
      • sore throat
      • toothache
      • headache

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use
    • with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use

    if your child has liver disease.

    Ask a doctor or pharmacist before use

    if your child is taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dose.

    (see overdose warning)

    Stop use and ask a doctor if
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    Keep out of reach of children.

  • Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.


  • Directions

    • do not give more than directed (see overdose warning)
    • shake well before use
    • this product does not contain directions or complete warnings for adult use
    • use only with enclosed dosing device
    • fill to dose level
    • dispense liquid slowly into child’s mouth towards inner cheek
    • repeat dose every 4 hours if needed
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
    • use dropper to close bottle and maintain child resistance
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    Weight (lb) Age (yr) Dose (mL)
    Under 24 Under 2 ask a doctor
    24-35 2-3 1.6 mL (0.8 + 0.8 mL)

  • Other information

    store between 20-25ºC (68-77ºF)


  • Inactive ingredients:

    butyl paraben, citric acid, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum.


  • Questions or comments?

    call 1-888-474-3099

    Distributed by:
    Blacksmith Brands Inc.
    200 White Plains Road
    Tarrytown, NY 10591 USA
    © 2010


  • PRINCIPAL DISPLAY PANEL

    NEW PediaCare® Infants
    Fever Reducer Pain Reliever
    Ludens® Cherry Taste!
    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL
PediaCare Infants Fever Reducer 
Cherry Flavor


  • INGREDIENTS AND APPEARANCE
    PEDIACARE INFANTS FEVER REDUCER CHERRY 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-393
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52183-393-01 1 in 1 BOX
    1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 08/27/2010
    Labeler - Blacksmith Brands, Inc. (021411299)
    Establishment
    Name Address ID/FEI Business Operations
    Guardian Drug Company 119210276 MANUFACTURE