FDA Label for Acetaminophen

Other

Drug Facts

Distributed By McKesson
One Post Street, San Francisco, CA 94104

Active Ingredient (In Each Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

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
  
  

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

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

• pain gets worse or lasts more than 10 days in adults and in children 12 years and over
• pain gets worse or lasts more than 5 days in children under 12 years
• 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 and over	take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours
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
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

Other Information

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

Inactive Ingredients

crospovidone, methylparaben, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid

Principal Display Panel - 325 Mg Tablet Bottle Carton

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COMPARE TO REGULAR STRENGTH
TYLENOL® ACTIVE INGREDIENT†

NDC 49348-973-10

pain reliever

Regular Strength

See New Warnings Information

Pain reliever & Fever reducer

ACETAMINOPHEN

100 TABLETS 325 mg EACH