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

Children Acetaminophen Grape Flavored Chewable

ACTIVE INGREDIENT (IN EACH TABLET)

Acetaminophen 80 mg

PURPOSE

Analgesic/Antipyretic

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, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose.

DISPLAY PANEL

picture of carton

CHILDREN ACETAMINOPHEN GRAPE FLAVORED CHEWABLE 
acetaminophen  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62211-165
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  
FD&C BLUE NO. 1  
Product Characteristics
Color purple Score no score
Shape ROUND Size 10mm
Flavor Imprint Code AZ023
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62211-165-99 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: 09/2010A&Z Pharmaceutical, Inc.