USES

Temporary relief of minor aches and pains associated with ■ common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ arthritis ■ menstrual cramps ■ and reduction of fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 8 tablets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

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 user has liver disease

Ask a Doctor/Pharmacist before use if you

are taking the blood thinning drug warfarin

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

If pregnant or breast-feeding,

ask a health professional before use

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

Directions

Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours;

Children under 12 years of age: do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

■ store at room temperature 59º-86º F (15º-30º C) ■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, pregelatinized starch, stearic acid. May contain povidone and sodium starch glycolate.

DISPLAY PANEL

ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	62211-011 (011)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ011
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	62211-011-99	27000 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	03/16/2004

Labeler - A&Z Pharmaceutical, Inc. (926820705)

Registrant - A&Z Pharmaceutical, Inc. (926820705)

Revised: 04/2010A&Z Pharmaceutical, Inc.