Drug Facts
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol Extra Strength / Tylenol Precise Cooling Pain Relief (NDC 50580-142). 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 drug facts, active ingredient (in each gelcap), purpose, uses, liver warning, other, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Acetaminophen 500 mg
Pain reliever/fever reducer
Topical analgesic
Topical analgesic
■ temporarily relieves minor aches and pains due to:
■ temporarily reduces fever
For the temporary relief of pain
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:
If a skin reaction occurs, stop use and seek medical help right away.
■ 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
▪ in large quantities, particularly over raw surfaces or blistered areas
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.
■ 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.
▪ condition worsens or symptoms persist for more than 7 days
▪ symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
| adults and children
12 years and over | ■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps 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 |
■ use only as directed
■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
■ children under 12 years of age: ask a doctor
■ store between 20-25°C (68-77°F). Avoid high humidity.
■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing.
store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)
benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide
carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Lidocaine 4%
Menthol 1%
For external use only.
▪ avoid contact with eyes
Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)
NDC 50580-142-01
Extra Strength
TYLENOL ®
FOR ADULTS
Acetaminophen
Pain Reliever
Fever Reducer
RAPID RELEASE GELS
Actual Size
225 Gelcaps*
500 mg each
*Gelatin-Coated Tablets
+ FREE BONUS ITEM
TYLENOL ®
PRECISE TM
Cooling†
Pain Relieving Cream
Lidocaine 4% Menthol 1%
Fast acting †
Targeted penetrating
pain relief
Maximum Strength Lidocaine
without a prescription
LIGHTLY SCENTED
For external use only
NET WT. 0.5 OZ (14.2 g)
* Please review the disclaimer below.