Label: PEDIACARE INFANTS FEVER REDUCER GRAPE- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 8, 2010

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  • 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 24Under 2ask a doctor
    24-352-31.6 mL (0.8 + 0.8 mL)
  • Other information

    store between 20-25ºC (68-77ºF)

  • Inactive ingredients:

    butyl paraben, citric acid, D&C Red #33, FD&C blue #1, 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® Grape Taste!
    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL PediaCare Infants Fever Reducer Grape Flavor

  • INGREDIENTS AND APPEARANCE
    PEDIACARE INFANTS FEVER REDUCER GRAPE 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-373
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-373-011 in 1 BOX
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/03/2010
    Labeler - Blacksmith Brands, Inc. (021411299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE
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