Tylenol
FDA Label NDC 50580-600

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.

Acetaminophen 325 mg

Pain reliever/fever reducer

• 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

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (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

• 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

• 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 reach of children.

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.

• do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 4 to 6 hours while symptoms last do not take more than 10 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years	take 1 caplet every 4 to 6 hours while symptoms last do not take more than 5 caplets in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

• store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if any individual blister unit is open or torn

carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium starch glycolate, stearic acid, titanium dioxide

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

325mg

NDC 50580-600-02
To re-order reference the NDC code

TYLENOL^®
Acetaminophen Pain Reliever - Fever Reducer
Regular Strength

EZ DOSE™

100 Caplets
325 mg each

10 Blister Cards
with
10 Individual Blisters

SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS

FOR HOSPITAL AND GOVERNMENT USE ONLY

Principal Display Panel (Tylenol 01)