CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable

Childrens Pain Relief by

Drug Labeling and Warnings

Childrens Pain Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-160
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	BUBBLE GUM	Imprint Code	RP160
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-160-24	4 in 1 CARTON	11/01/2017
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/01/2017

Labeler - CVS Pharmacy,Inc. (062312574)