FDA Label for Acetaminophen

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

Otc - Purpose

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

• headache 
• muscular aches 
• backache 
• minor pain of arthritis 
• common cold 
• toothache 
• premenstrual and
• menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. 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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening ,blisters, rash. If a skin reaction occurs, stop use and seek medical help right away.

Otc - 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

Otc - Ask Doctor

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

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.

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.

Overdosage

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)

adults and children 12 years and over:

• take 2 tablets every 6 hours while symptoms last

• do not take more than 6 tablets in 24 hours, unless directed by a doctor

• do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other Information

store at room temperature

Inactive Ingredient

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

Call (800) 616-2471

Other

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

16 How Supplied/Storage And Handling

Acetaminophen tablets, 325 mg are supplied as white, scored round tablets, debossed with “54;27”.

In bottles of 20: (NDC 72789-241-20)

In bottles of 30: (NDC 72789-241-30)

In bottles of 50: (NDC 72789-241-50)

In bottles of 60: (NDC 72789-241-60)

In bottles of 100: (NDC 72789-241-01)

Package Label.Principal Display Panel

Acetaminophen Extra Strength Tablets

Extra Strenght Pain reliever

500mg each

72789241 Label - 72789241