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
■ 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
■ 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 2...
■ store between 20-25°C (68-77°F) ■ do not use if blister unit is torn or broken
Drug Facts
Acetaminophen 325 mg
Pain reliever/fever reducer
■ 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
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
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.
■ 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
■ has liver disease ■ is a child with pain of arthritis
Ask a doctor or pharmacist before use if the user is taking the blood thinning
drug warfarin.
■ 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
■ 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 not use for more than 5 days unless directed by a doctor |
children under 6 years | ask a doctor |
■ store between 20-25°C (68-77°F)
■ do not use if blister unit is torn or broken
carnauba wax, hypromellose, magnesium stearate,powdered cellulose, pregelatinized starch, sodium starch glycolate
Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
325 mg
NDC 50580-475-11
To re-order reference the NDC Code
TYLENOL®
Acetaminophen Pain Reliever - Fever Reducer
Regular Strength
FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE.
PACKAGE IS NOT CHILD-RESISTANT.
100 Caplets
325 mg each
10 Blister Cards
with
10 Individual Blisters
SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 1 |
| 209387 | Tylenol Regular Strength 325 MG Oral Tablet | PSN | 1 |
| 209387 | acetaminophen 325 MG Oral Tablet [Tylenol] | SBD | 1 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 1 |
| 313782 | APAP 325 MG Oral Tablet | SY | 1 |
| 209387 | APAP 325 MG Oral Tablet [Tylenol] | SY | 1 |
| 209387 | Tylenol 325 MG Oral Tablet | SY | 1 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-475-10 | TYLENOLRegular Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 50580-475-10 | TYLENOLRegular Strength | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 1 | |
| 50580-475-11 | TYLENOLRegular Strength | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 1 | |
| 50580-475-11 | TYLENOLRegular Strength | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 1 | |
| 50580-475-50 | TYLENOLRegular Strength | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 1 | |
| 50580-475-50 | TYLENOLRegular Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-475-11 | EA - Each | 50580-475 | 8f4013b0-191a-4cea-b5f0-9eca1cdac685 | 1 | 2025-12-16 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-475 | 50580-475-11, 50580-475-50, 50580-475-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 | 398d8996-b522-a3cd-e063-6394a90ac2c8 | 2025-08-06 | Warnings | 50580-475-50 50580-475-10 50580-475-11 50580-475 50580047511 50580047510 50580047550 398d8996-b523-a3cd-e063-6394a90ac2c8 398d8996-b522-a3cd-e063-6394a90ac2c8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.