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
- Kenvue Brands LLC
- Effective date
- 2026-06-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 24
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:41:50
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 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
Storage and handling
store between 20-25°C (68-77°F) do not use if pouch is torn or damaged
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
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
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 |
|
| 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
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
NDC 50580-449-10
TYLENOL
®
FOR ADULTS
Acetaminophen
Pain Reliever
Fever Reducer
Extra Strength
50 Pouches of
2 Caplets each
500 mg each
50 Pouches of 2 Caplets each – 500 mg each
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0300450449108 | GTIN-13: 0300450449108 EAN-13: 0300450449108 GTIN-12: 300450449108 UPC-A: 300450449108 GTIN storage (14 digits): 00300450449108 | tylenol-01.jpg |
| Data code | Code 128 | 30063511 | tylenol-01.jpg |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 5 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 5 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 5 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | 5 | |
| castor oil | INACTIVE INGREDIENT | D5340Y2I9G | 5 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 5 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 5 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 5 | |
| powdered cellulose | INACTIVE INGREDIENT | SMD1X3XO9M | 5 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| shellac | INACTIVE INGREDIENT | 46N107B71O | 5 | |
| sodium starch glycolate type A potato | INACTIVE INGREDIENT | 5856J3G2A2 | 5 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | 5 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 5 |
Products#
Every source-derived product name is available through these pages.
- TYLENOL Extra Strength
- Acetaminophen
- STARCH, CORN
- CARNAUBA WAX
- FD&C RED NO. 40
- ALUMINUM OXIDE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POWDERED CELLULOSE
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM STARCH GLYCOLATE TYPE A
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-449 | 50580-449-00, 50580-449-05, 50580-449-08, 50580-449-09, 50580-449-10, 50580-449-11, 50580-449-13, 50580-449-14, 50580-449-15, 50580-449-23, 50580-449-31, 50580-449-34, 50580-449-35, 50580-449-36, 50580-449-61, 50580-449-62, 50580-449-84, 50580-449-85, 50580-449-86, 50580-449-87, 50580-449-12, 50580-449-96, 50580-449-97, 50580-449-98, 50580-449-66, 50580-449-37 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 23 | 2026-01-21 | full-release | 2026-06-01 01:35:55 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, FILM COATED / ORAL | 392 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, FILM COATED / ORAL | 392 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, FILM COATED / ORAL | 392 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, FILM COATED / ORAL | 392 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| aluminum oxide | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| powdered cellulose | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, FILM COATED / ORAL | 392 mg | ||
| castor oil | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| carnauba wax | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.