Indications and 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
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2024-11-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:40:00
Label at a glance#
ProductTYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
Active ingredientACETAMINOPHEN, LIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure18 sections
Dosage and administration
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
Storage and handling
■ 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.
Contacts and useful links#
Label contents#
Full prescribing information#
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
SPL UNCLASSIFIED SECTION
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 SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 1 |
| 250912 | lidocaine 4 % / menthol 1 % Topical Cream | PSN | 1 |
| 209459 | Tylenol Extra Strength 500 MG Oral Tablet | PSN | 1 |
| 209459 | acetaminophen 500 MG Oral Tablet [Tylenol] | SBD | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 1 |
| 250912 | lidocaine 40 MG/ML / menthol 10 MG/ML Topical Cream | SCD | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | 1 |
| 209459 | APAP 500 MG Oral Tablet [Tylenol] | SY | 1 |
| 250912 | lidocaine 4 % / menthol 1 % Topical Cream | SY | 1 |
| 209459 | Tylenol 500 MG Oral Tablet | SY | 1 |
| 209459 | Tylenol Extra Strength 500 MG Oral Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-142-01 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 1 in 1 KIT | KIT | 1 | 1 | |
| 50580-490-25 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 225 in 1 BOTTLE | TABLET, COATED | 225 | 500 mg | 1 |
| 50580-490-25 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 1 in 1 CARTON | TABLET, COATED | 500 mg | 1 | |
| 69968-0793-1 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 1 in 1 CARTON | CREAM | 40 mg in 1g | 1 | |
| 69968-0793-1 | TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | 14.2 g in 1 TUBE | CREAM | 14.2 g | 40 mg in 1g | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-142 | TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC] | 1 | Current NDC, 5 package rows | 20241204_2611e984-0dd5-bda1-e063-6394a90a559a.zip |
| 50580-490 | TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC] | 1 | Current NDC, Legacy NDC | 20241204_2611e984-0dd5-bda1-e063-6394a90a559a.zip |
| 69968-0793 | TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC] | 1 | Current NDC | 20241204_2611e984-0dd5-bda1-e063-6394a90a559a.zip |
Products#
Every source-derived product name is available through these pages.
- TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
- Acetaminophen, Lidocaine, Menthol
- TYLENOL Extra Strength
- Acetaminophen
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYSORBATE 80
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- FD&C BLUE NO. 1
- FERRIC OXIDE YELLOW
- POWDERED CELLULOSE
- PROPYLENE GLYCOL
- D&C YELLOW NO. 10
- SODIUM LAURYL SULFATE
- BUTYLPARABEN
- GELATIN, UNSPECIFIED
- EDETATE CALCIUM DISODIUM
- HYPROMELLOSE, UNSPECIFIED
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
- BENZYL ALCOHOL
- METHYLPARABEN
- PROPYLPARABEN
- SODIUM PROPIONATE
- SODIUM STARCH GLYCOLATE TYPE A
- Tylenol Precise Cooling Pain Relieving
- Lidocaine, Menthol
- PHENOXYETHANOL
- SORBITAN OLIVATE
- GLYCERIN
- LIDOCAINE
- CETEARYL OLIVATE
- WATER
- SODIUM POLYACRYLATE (2500000 MW)
- ISOPROPYL PALMITATE
- MENTHOL, UNSPECIFIED FORM
- MENTHOL
- CETYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-142 | 50580-142-01 |
| 50580-490 | 50580-490-25 |
| 69968-0793 | 69968-0793-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 201b860d-dc3c-4380-affa-e757bf2103cf | 2026-04-07 | Warnings | 50580-490-25 50580-490 50580049025 |
| Tylenol Precise Cooling Pain Relieving | LIDOCAINE, MENTHOL | Kenvue Brands LLC | fc0a3404-b174-3952-e053-6294a90a1e02 | 2026-02-16 | Warnings | 69968-0793-1 69968-0793 69968079301 |
| TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief | ACETAMINOPHEN, LIDOCAINE, MENTHOL | Kenvue Brands LLC | 2611e984-0dd5-bda1-e063-6394a90a559a | 2024-11-26 | Warnings | 69968-0793-1 50580-490-25 50580-142-01 50580-142 50580049025 50580014201 69968079301 2611d7e2-4446-b6b6-e063-6394a90a6232 2611e984-0dd5-bda1-e063-6394a90a559a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.