PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY- acetaminophen liquid 
Blacksmith Brands, Inc.

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

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 24 under 2 ask a doctor
 24-35 2-3 1 teaspoon or 5 mL
 36-47 4-5 1 ½ teaspoons or 7.5 mL
 48-59 6-8 2 teaspoons or 10 mL
 60-71 9-10 2 ½ teaspoons or 12.5 mL
 72-95 11 3 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)

PRINCIPAL DISPLAY PANEL PediaCare Childrens Fever Reducer Pain Reliever Cherry Flavor
PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-335
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-335-041 in 1 BOX07/08/201008/01/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/08/201008/01/2017
Labeler - Blacksmith Brands, Inc. (159655021)

Revised: 9/2017
 
Blacksmith Brands, Inc.