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
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2026-01-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 01:35:17
Label at a glance#
ProductTYLENOL Regular Strength
Active ingredientACETAMINOPHEN
Label structure11 sections
Dosage and administration
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 to 6 hours while symptoms last do not take more than 10 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 caplet every 4 to 6 hours while symptoms last do not take more than 5 caplets in 24 hours do ...
Storage and handling
store between 20-25°C (68-77°F) do not use if blister unit is torn or broken
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 325 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. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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 the user
- has liver disease
- is a child with pain of arthritis
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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 6 years to under 12 years |
|
| children under 6 years | ask a doctor |
Other information
- store between 20-25°C (68-77°F)
- do not use if blister unit is torn or broken
Inactive ingredients
carnauba wax, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide
Questions or comments?
Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
325mg
NDC 50580-458-11
To re-order reference the NDC Code
TYLENOL ®
Acetaminophen Pain Reliever - Fever Reducer
Regular Strength
100 Caplets
325 mg each
10 Blister Cards
with
10 Individual Blisters
SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS
FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE.
PACKAGE IS NOT CHILD-RESISTANT.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 10 |
| 209387 | Tylenol Regular Strength 325 MG Oral Tablet | PSN | 10 |
| 209387 | acetaminophen 325 MG Oral Tablet [Tylenol] | SBD | 10 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 10 |
| 313782 | APAP 325 MG Oral Tablet | SY | 10 |
| 209387 | APAP 325 MG Oral Tablet [Tylenol] | SY | 10 |
| 209387 | Tylenol 325 MG Oral Tablet | SY | 10 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | ITF | 129948 | tylenol-1.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-458-10 | TYLENOLRegular Strength | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | 10 | |
| 50580-458-11 | TYLENOLRegular Strength | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 10 | |
| 50580-458-11 | TYLENOLRegular Strength | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 10 | |
| 50580-458-50 | TYLENOLRegular Strength | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | 10 | |
| 50580-458-50 | TYLENOLRegular Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-458-10 | EA - Each | 50580-458 | 5ac6a4e4-2110-4ea2-b0ed-eb39c2e32c12 | 1 | 2021-07-15 |
| 50580-458-11 | EA - Each | 50580-458 | 593b38c3-888b-445c-b664-25853a791c1c | 1 | 2021-02-05 |
Products#
Every source-derived product name is available through these pages.
- TYLENOL Regular Strength
- acetaminophen
- CARNAUBA WAX
- STARCH, CORN
- FD&C RED NO. 40
- ALUMINUM OXIDE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- POWDERED CELLULOSE
- PROPYLENE GLYCOL
- SHELLAC
- TITANIUM DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50580-458 | 50580-458-11, 50580-458-50, 50580-458-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 Regular Strength | ACETAMINOPHEN | Kenvue Brands LLC | 01f41fae-4abb-4b96-ab09-a7d3dfc286cd | 2026-01-26 | Warnings | 50580-458-50 50580-458-10 50580-458-11 50580-458 50580045810 50580045811 50580045850 49576408-6940-93c6-e063-6394a90a6fa8 01f41fae-4abb-4b96-ab09-a7d3dfc286cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.