Indications and uses
■ temporarily relieves minor aches and pains due to: - the common col - headache - backache - minor pain of arthritis - toothach - muscular aches - premenstrual and menstrual cramps ■ temporarily reduces fever
TYLENOL® Extra Strength
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2026-06-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-06-11 05:10:27
Label at a glance#
ProductTYLENOL Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
■ do not take more than directed (see overdose warning) adults andchildren 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets 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) ■ 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#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Purpose
Pain reliever/fever reducer
Uses
■ temporarily relieves minor aches and pains due to:
- the common col
- headache
- backache
- minor pain of arthritis
- toothach
- muscular aches
- premenstrual and menstrual cramps
■ temporarily reduces fever
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
■ 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
OTC - STOP USE SECTION
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 andchildren
12 years and over | ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets 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)
■
do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing
Inactive ingredients
carnauba wax, crospovidone, FD&C red no. 40, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
PRINICIPAL DISPALY PANEL
NDC 50580-108-25
TYLENOL ®
FOR ADULTS
Acetaminophen
Pain Reliever
Fever Reducer
Extra Strength
Actual Size
225 Caplets
500 mg each
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450444271 | GTIN-13: 0300450444271 EAN-13: 0300450444271 GTIN-12: 300450444271 UPC-A: 300450444271 GTIN storage (14 digits): 00300450444271 | tylenol-1.jpg |
| Data code | Code 128 | 30060111 | tylenol-1.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- TYLENOL Extra Strength
- acetaminophen
- CROSPOVIDONE, UNSPECIFIED
- STEARIC ACID
- TITANIUM DIOXIDE
- POVIDONE
- MAGNESIUM STEARATE
- SODIUM STARCH GLYCOLATE TYPE A
- PROPYLENE GLYCOL
- CARNAUBA WAX
- FD&C RED NO. 40
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-108 | 50580-108-25, 50580-108-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-03-18 | full-release | 2026-06-01 01:51:39 |
| 1 | 2025-09-25 | monthly-update | 2026-06-03 17:38:32 |
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 | 3f653262-b931-7d42-e063-6394a90adddd | 2026-06-03 | Warnings | 50580-108-20 50580-108-25 50580-108 50580010825 50580010820 53536dcd-8f52-e352-e063-6294a90aa943 3f653262-b931-7d42-e063-6394a90adddd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.