Acetaminophen

Cardinal Health

Acetaminophen, USP 325 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Keep Out of Reach of Children
• Acetaminophen Uses
• Warnings
• Directions
• Inactive ingredients
• Storage
• How Supplied:
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of reach of children.

Acetaminophen Uses

Temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever.

Warnings

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use with any other product containing acetaminophen

Stop use and ask a doctor if:

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

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do not take more than directed (see overdose warning)

Adults and children 12 years of age and over

• take 2 tablets every 4 to 6 hours while symptoms last
• do not take more than 12 tablets in 24 hours
• do not use more than 10 days unless directed by a doctor

Children 6-11 years

• take 1 tablet every 4 to 6 hours while symptoms last
• do not take more than 5 tablets in 24 hours
• do not use for more than 5 days unless directed by a doctor

Children under 6 years

• do not use this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive ingredients

pregelatinized starch, povidone, stearic acid

Storage

Store between 20-25 C (68-77 F)

Do not use if blister units are torn, or show any signs of tampering.

Questions? 1-800-848-0462

Serious side effects associated with use of this product may be reported to this number.

How Supplied:

Acetaminophen Tablets are available as follows:

325 mg - White, round, flat faced, beveled tablets debossed "AN" above bisect and "211" below bisect on one side and plain on the other side.

NDC 51079-002-20 - Unit dose blister packages of 100 (10 cards of 10 talbets each).

NDC 51079-002-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each).

NDC 51079-002-22 - Unit dose blister packages of 200 (10 cards of 20 tablets each).

Store between 20-25C (68-77F).

ANUFACTURED BY:

Amneal Pharmaceuticals Corp.

Paterson, NJ 07504

Packaged and Distributed by:

UDL Laboratories, Inc. Rockford, IL 61103

S-8927 R4

11/08

Principal Display Panel

Acetaminophen Tablets, USP

325 mg

10 x 2 Tablets