ACETAMINOPHEN- acetaminophen tablet
A&Z Pharmaceutical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Acetaminophen Tablets, 325mg

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  ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses in 24 hours■ taken with other drugs containing acetaminophen ■ adult has 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

the user is 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 12 tablets in 24 hours;

Children 6-11 years of age: take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours;

Children under 6 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	Item Code (Source)	NDC:62211-010
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZ010
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62211-010-99	41200 in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	08/14/2009	05/08/2015

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

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

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	manufacture(62211-010)

Revised: 5/2015

Document Id: 0c1ad198-572e-4b2c-a459-30320047198a

Set id: e239a008-6ae3-4226-8947-865fb7fb63cc

Version: 4

Effective Time: 20150508

A&Z Pharmaceutical, Inc.