Medication Guide App

PediaCare Infants Fever Reducer Dye Free

Dosage form: liquid
Ingredients: ACETAMINOPHEN 80mg in 0.8mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-383

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.

PediaCare Infants Fever Reducer Dye Free

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, 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
Dye Free Ludens® Cherry Taste!
1 FL OZ (30 mL)

PEDIACARE INFANTS FEVER REDUCER DYE FREE 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-383
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CITRIC ACID 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-383-011 BOTTLE, DROPPER (1 BOTTLE) in 1 BOX
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/28/2010
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Guardian Drug Company119210276MANUFACTURE

Revised: 10/2010
 
Blacksmith Brands, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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