Acetaminophen

Cardinal Health

Acetaminophen 500 mg Caplets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Information
• Active ingredient (in each caplet)
• Purpose
• Keep Out of Reach of Children
• Acetaminophen Uses
• Warnings
• Directions
• Inactive ingredients
• How Supplied
• Storage
• Other Information
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Drug Information

Acetaminophen

500 mg Caplets

Extra Strength

Pain Reliever/Fever Reducer

Contains No Aspirin

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING

Active ingredient (in each caplet)

Acetaminophen 500 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 caplets every 4 to 6 hours while symptoms last
• do not take more than 8 caplets in 24 hours
• do not use for more than 10 days unless directed by a doctor
• Children under 12 years
• do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Inactive ingredients

pregelatinized starch, povidone, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, carnauba wax

How Supplied

How Supplied

Acetaminophen Extra Strength Caplets are available as follows:

500 mg - White to off-white, capsule shaped, film coated caplets with 112 debossed on one side.

NDC 51079-396-20 - Unit dose blister packages of 100 (10 cards of 10 caplets each).

NDC 51079-396-19 - Robot Ready blister packages of 25 (25 cards of 1 caplet each).

Storage

Store between 20-25°C (68-77°F)

Other Information

• do not use if blister units are torn, broken 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.

Manufactured by:

Amneal Pharmaceuticals Corp.

Paterson, NJ 07504

Packaged and Distributed by:

UDL Laboratories, Inc.

Rockford, IL 61103

S-8777 R3

1/09

Principal Display Panel

Acetaminophen Caplets

500 mg

Extra Strength

10 Caplets