Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Tylenol Extra Strength Tablet, Film Coated
FDA Label NDC 73097-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Savings Distributors Llc for the product Tylenol Extra Strength (NDC 73097-012). 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 ingredient (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 menstual cramps
■ temporarily reduces fever
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
Ifa 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 ■ take 2 capletes every 6 hours while symptoms
12 years and over: last
■ do not take more than 6 capletes 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 20-25C (68-77F)
■ do not use if pouch is torn or damaged.
Inactive Ingredients
carnauba wax*, corn starch*, FD&C red no.40 aluminum lake, hypromellose, magnesium stearate, modified starch*, 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)
Package Labeling
Package Label (Tylenolextrastrength 25)
* Please review the disclaimer below.
