FDA Label for Acetaminophen

Other

Drug Facts

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.

Distributed by: Brandywine Pharmaceuticals, LLC

Active Ingredient (In Each Tablet)

Acetaminophen USP, 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 or menstrual cramps
  • temporarily reduces fever
  
  

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
• child takes more than 5 tablets in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks 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
• pain gets worse or lasts more than 5 days in children
• 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. 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 4-6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years	take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years	do not use

Other Information

• store at 15° to 30°C (59° to 86°F)

Inactive Ingredients

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

Questions Or Comments?

call 1-800-647-0172, 8:30 am - 4:30 pm ET, Monday - Friday

Principal Display Panel - 325 Mg Tablet Bottle Label

NDC 71321-100-10

BRANDYWINE^®
PHARMACEUTICALS,LLC

Regular Strength
Acetaminophen USP
325 mg
PAIN RELIEVER
FEVER REDUCER

100 TABLETS

PRINCIPAL DISPLAY PANEL - 325 mg Tablet Bottle Label - acetaminophen 01