TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
- Dosage form
- KIT
- Labeler
- Kenvue Brands LLC
- Label updated
- 2024-11-26
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · LIDOCAINE · MENTHOL, UNSPECIFIED FORM
Drug Facts
Drug Facts
Active ingredient (in each gelcap)
Acetaminophen 500 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
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
Label information
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
Label information
Ask a doctor before use if you have liver disease
Label information
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.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
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 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 |
Other information
■ 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.
Inactive ingredients
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
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Active Ingredient
Lidocaine 4%
Menthol 1%
Purpose
Topical analgesic
Topical analgesic
Uses
For the temporary relief of pain
Warnings
For external use only.
Do not use
▪ in large quantities, particularly over raw surfaces or blistered areas
When using this product
▪ avoid contact with eyes
Stop use and ask a doctor if
▪ condition worsens or symptoms persist for more than 7 days
▪ symptoms clear up and occur again within a few days
Label information
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ 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
Other Information
store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)
Inactive Ingredients
carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water
Questions?
Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)
PRINCIPAL DISPLAY PANEL
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)
[Image in the official label — see DailyMed source]
DailyMed Set ID: 2611e984-0dd5-bda1-e063-6394a90a559a · Version 1
NDC: 50580-142