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CHILDREN ACETAMINOPHEN  - acetaminophen tablet, chewable 
A&Z Pharmaceutical, Inc.

Children Acetaminophen, 80mg, Fruit Flavored Chewable Tablets

USES

Temporary relief of minor aches and pains associated with ■ common cold and flu ■ headache ■ toothache ■ sore throat ■ immunizations ■ and reduction of fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if ■ your child takes more than 5 doses in 24 hours ■ taken 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

Ask a Doctor

before use if your child has liver disease

Ask a Doctor/Pharmacist before use if you

are taking the blood thinning drug warfarin

When using this product do not exceed recommended dose;

taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

Stop Use and ask a doctor if

■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt 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 ■ chew tablets before swallowing ■ all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period ■ follow the chart below for proper dosing or as directed by a doctor ■ if possible, use weight for dosing, otherwise use age.

Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95
Age (yrs) Under 2 2-3 4-5 6-8 9-10 11
Tablets Consult a doctor 2 3 4 5 6

Other information

■ Phenylketonurics: contains phenylalanine 2.8 mg per tablet ■ store at room temperature ■ protect from excessive moisture ■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose.

DISPLAY PANEL

picture of carton

CHILDREN ACETAMINOPHEN 
children acetaminophen  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62211-023 (023)
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  
CROSCARMELLOSE SODIUM  
D&C RED NO. 7  
MANNITOL  
Product Characteristics
Color pink Score no score
Shape ROUND Size 10mm
Flavor Imprint Code AZ023
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62211-023-30 30 TABLET In 1 BOTTLE None
2 62211-023-99 37500 TABLET In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 03/10/2022

Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Revised: 04/2010A&Z Pharmaceutical, Inc.