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Drug Facts
Tylenol Tablet, Film Coated
FDA Label NDC 50580-475
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol (NDC 50580-475). 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 other, active ingredient (in each caplet), purpose, uses, warnings, liver warning, allergy alert, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Warnings
Warnings
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
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 The User
■ has liver disease ■ is a child with pain of arthritis
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)
■ do not use if blister unit is torn or broken
Inactive Ingredients
carnauba wax, hypromellose, magnesium stearate,powdered cellulose, pregelatinized starch, sodium starch glycolate
Otc - Questions
Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
325 mg
NDC 50580-475-11
To re-order reference the NDC Code
TYLENOL®
Acetaminophen Pain Reliever - Fever Reducer
Regular Strength
FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE.
PACKAGE IS NOT CHILD-RESISTANT.
100 Caplets
325 mg each
10 Blister Cards
with
10 Individual Blisters
SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS
Tylenol-1 (Tylenol 1)
* Please review the disclaimer below.
