Acetaminophen

AAA Pharmaceutical, Inc.

Acetaminophen Caplets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• Acetaminophen Uses
• Warnings
  • Liver warning
  • Do not use
  • Stop use and ask a doctor if
  • Keep out of reach of children.
  • Overdose warning
• Directions
• Acetaminophen Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Acetaminophen Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• 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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts 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.

Keep out of reach of children.

Overdose warning

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)

Acetaminophen Other information

• store between 20-25°C (68-77°F)
• retain carton for complete product information

Inactive ingredients

acesulfame potassium, flavor, hypromellose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

RESTORE u

NDC 57344-098-02

^†COMPARE TO THE ACTIVE
INGREDIENT IN TYLENOL^®
EXTRA STRENGTH
COOL CAPLETS

EXTRA
STRENGTH
CONTAINS NO ASPIRIN

COOL BLAST
INSTANT COOLING SENSATION

Easy To
Swallow

Pain Relief
Pain Reliever, Fever Reducer
Contains Acetaminophen

50 CAPLETS - 500 mg each