FDA Label for Acetaminophen

Active Ingredient (In Each Tablet)

Acetaminophen 325mg

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.

Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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.

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 The User Has

liver disease

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
• 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of The Reach Of Children.

Overdose Warning:

In the 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 10 tablets in 24 hours, unless directe by a doctor do not use for more than 10 days unless directed by a doctor
children 6 to 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	ask a doctor

Other Information

• store between 20-25°C (68-77°F)
• TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-645-2158

16 How Supplied/Storage And Handling

Acetaminophen tablets, 325 mg are supplied as white, round tablets, debossed with “PH020”.

In bottles of 20: (NDC 72789-267-20)

Package Label.Principal Display Panel

Regular Strength

Acetaminophen

325 mg 

72789267 Label - 72789267