Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Tylenol Extra Strength Tablet, Film Coated
FDA Label NDC 67751-167
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Tylenol Extra Strength (NDC 67751-167). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
• temporarily relieves minor aches and pains due to:
• the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches
• premenstrual and menstrual cramps
• temporarily reduces fevers
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.
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 You Have
• liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor |
| children under 12 years | ask a doctor |
Other Information
• store between 20-25°C (68-77°F)
• see bottom of carton for lot number and expiration date
• do not use if pouch is opened
Inactive Ingredients
carnauba wax*, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide
*contains one or more of these ingredients
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
* Please review the disclaimer below.
