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Drug Facts
Tylenol Extra Strength Suspension
FDA Label NDC 50580-187
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 Extra Strength (NDC 50580-187). 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 30 ml), 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 30 Ml)
Acetaminophen 960 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. 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
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
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)
■ shake well before using
■ remove child protective cap
■ squeeze the dose into the dosing cup
■ mL = milliliter
| adults and children 12 years and over | ■ take 30 mL (2 x 15 mL) every 6 hours while symptoms last. For dosing, the dosing cup needs to be filled to 15 mL line twice.
■ do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor |
| children under 12 years | ■ ask a doctor |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
■ each 30 mL contains:
potassium 30 mg
■ store between 20-25°C (68-77°F)
■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing
Inactive Ingredients
anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum
Questions Or Comments?
Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-187-08
NEW
Extra Strength
TYLENOL
®
FOR ADULTS
Acetaminophen (960 mg per 30 mL)
Oral Suspension
Pain Reliever-Fever Reducer
Adult Liquid
Pain Reliever
Dye-Free
Alcohol Free
8 fl oz (240 mL)
960 mg per 30 mL
Cherry Flavor
Tylenol-1 (Tylenol 1)
* Please review the disclaimer below.
