Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Tylenol Extra Strength
- Manufacturer
- JC World Bell Wholesale Co., Inc. | McNeil Healthcare LLC | Kenvue Brands LLC
- Effective date
- 2026-05-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-06-16 05:10:23
Label at a glance#
ProductTylenol Extra Strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- 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
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
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
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,
ask a health professional before use.
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 |
|
| children under 12 years | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
- do not use if pouch is torn or damaged
Inactive ingredients
carnauba wax*, corn starch*, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide
*contains one or more of these ingredients
Questions or comments?
call 1-877-895-3665(toll-free) or 215-273-8755(collect)
Package Labeling:
Package Labeling:
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0852682507779 | GTIN-13: 0852682507779 EAN-13: 0852682507779 GTIN-12: 852682507779 UPC-A: 852682507779 GTIN storage (14 digits): 00852682507779 | Label.jpg |
| QR code link | QR Code |  hi.tylenol.com/ESTCAP225 | Label.jpg |
DailyMed Billing Units#
Products#
Every source-derived product name is available through these pages.
- Tylenol Extra Strength
- ACETAMINOPHEN
- CARNAUBA WAX
- STARCH, CORN
- FD&C RED NO. 40 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POWDERED CELLULOSE
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50269-449 | 50269-449-25, 50269-449-20 |
| 50580-449 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2023-11-05 | full-release | 2026-05-31 23:58:59 |
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 | 59773893-09a8-47a2-943a-e9ea9da4458a | 2026-06-15 | Warnings | 50580-449 |
| 52408cc6-3411-d0e2-e063-6394a90a942f | 68b0be18-198e-48c7-a7a2-e81cbcf0fbe8 | 2026-05-20 | Warnings | 52408cc6-3411-d0e2-e063-6394a90a942f 68b0be18-198e-48c7-a7a2-e81cbcf0fbe8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.