FDA Label for Tylenol Regular Strength

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.

Active Ingredient (In Each Caplet)

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. 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

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 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 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

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 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

Other Information

• 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

Inactive Ingredients

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

Questions Or Comments?

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

Principal Display Panel

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