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Childrens Pain Relief by CVS Pharmacy,Inc.

Medically reviewed on November 2, 2017

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 160mg
Labeler: CVS Pharmacy,Inc.
NDC Code: 69842-160

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.

Children’s Pain Relief Acetaminophen 160mg Dye Free Bubblegum Flavor Chewable Tablets

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses
temporarily relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
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.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away

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 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 at 1-800-222-1222. 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.
do not give more than directed (see overdose warning)
find the right dose on chart below. If possible, use weight to dose; otherwise use age.
chew before swallowing
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lbs)

under 24

24-35

36-47

48-59

60-71

72-95

Age (yrs)

under 2 years

2-3- years

 4-5 years

6-8 years

9-10 years

11 years

Dose(tablets)*

 ask a doctor

 1

1 1/2

2

2 1/2

3

 
*or as directed by a doctor

Other information
store at room temperature Avoid high humidity.
see end flap for expiration date and lot number
keep this carton for future reference on full labeling

Inactive ingredients

citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC 69842-160-24

Compare to the active ingredient in Children’s Tylenol® Chewables†

Children’s

Pain Relief

Acetaminophen 160 mg

Pain reliever/Fever reducer

Ages 2-11

Free of: Aspirin & Ibuprofen

BUBBLEGUM FLAVOR

24 CHEWABLE TABLETS

160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

Distributed by: CVS Pharmacy, Inc,

One CVS Drive, Woonsocket, RI 02895

©2017 CVS/Pharmacy

CVS.com 1-800-SHOP CVS

CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
CROSPOVIDONE 
DEXTROSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
STARCH, CORN 
SUCRALOSE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize16mm
FlavorBUBBLE GUMImprint CodeRP160
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-160-244 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2017
Labeler - CVS Pharmacy,Inc. (062312574)

 
CVS Pharmacy,Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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