Medication Guide App

PediaCare Childrens Fever Reducer Pain Reliever Cherry

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-335

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 Childrens Fever Reducer Cherry

Drug Facts

Active ingredient

(in each 5 mL, 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily reduces fever

temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if your 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Keep this and all drugs out of the reach of children.

Overdose Warning: 

Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • this product does not contain directions or complete warnings for adult use.
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • tsp = teaspoon, mL = milliliter
Weight (lb)Age (yr)Dose (tsp or mL)
under 24under 2ask a doctor
24-352-31 teaspoon or 5 mL
36-474-51 ½ teaspoons or 7.5 mL
48-596-82 teaspoons or 10 mL
60-719-102 ½ teaspoons or 12.5 mL
72-95113 teaspoons or 15 mL

Other information
  • store at room temperature
  • each teaspoon contains: sodium 2 mg
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 40, sodium benzoate, sorbitol, 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

PediaCare®
Children’s
Fever Reducer
Pain Reliever
Luden’s® Cherry Taste!
4 FL OZ (118 mL)

PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-335
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
POWDERED CELLULOSE 
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
FD&C RED NO. 40 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-335-041 BOTTLE (1 BOTTLE) in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/08/2010
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Aaron Industries113044205MANUFACTURE

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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