Active Ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purposes

Pain Reliever/Fever Reducer

Uses

Temporarily relieves minor aches and pain 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.

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 other drug containing acetaminophen (prescription or non prescription). 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.

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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

■ This products does not contain directions or complete warnings for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.

Weight	Age	Tablets
Under 24 lbs	Under 2 years	Ask a doctor
24-35 lbs	2-3 years	2 tablets
36-47 lbs	4-5 years	3 tablets
48-59 lbs	6-8 years	4 tablets
60-71 lbs	9-10 years	5 tablets
72-95 lbs	11 years	6 tablets

Other Information

Phenylketonurics: Contain Phenylalanine 14 mg per tablet
Do not use if imprinted safety seal under cap is broken or missing
Store at room temperature in a dry place

Inactive Ingredients

Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

Questions?

Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

image of package label

NDC 54868-5625-0

*Compare to the active ingredient in Children's Chewable Tylenol®

Children's Chewable

AGES 2-6

Acetaminophen Chewable Tablets

30 Tablets, 80 mg EACH

Fever reducer/ Pain reliever

ASPIRIN FREE ● IBUPROFEN FREE

See New Warnings Information

Fruit Flavor

ACETAMINOPHEN
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	54868-5625 (0904-5256)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
POVIDONE
STARCH, CORN
SODIUM CHLORIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SORBITOL
STEARIC ACID
SUCRALOSE

Product Characteristics
Color	pink	Score	no score
Shape	ROUND (ROUND BICONVEX TABLET)	Size	10mm
Flavor		Imprint Code	1G
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	54868-5625-0	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
1		30 TABLET In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (54868-5625-0)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	06/29/2006

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 06/2012Physicians Total Care, Inc.