CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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.

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Active ingredient

 (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever / fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe 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 nonprescription). 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 dosage

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warning for adult use
  • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
 Weight (lb) Age (yr) Tablets
 under 24 under 2 Ask a doctor
 24-35 2-3 2
 36-47 4-5 3
 48-59 6-8 4
 60-71 9-10 5
 72-95 11 6

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active ingredient

in Children's Tylenol®*

See New Warnings

Information

Children's

PAIN RELIEF

AGES 2-6

CONTAINS ACETAMINOPHEN

Fever reducer / Pain reliever

30 TABLETS

ASPIRIN FREE ● IBUPROFEN FREE

RAPID TABS

Bubblegum Flavor

80 mg PER TABLET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844           REV0410B44701

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

Product Label
CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-447
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 27 
D&C RED NO. 30 
DEXTROSE 
ETHYLCELLULOSES 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize13mm
FlavorBUBBLE GUMImprint Code 44;447
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-447-011 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/03/2005
Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 05/2011
Document Id: b10e25e8-5f76-4f7b-a490-0502af1e4234
Set id: 44ed55ef-f0d3-f11d-7204-cfa433669c28
Version: 3
Effective Time: 20110511
 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED