Label: TYLENOL REGULAR STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 50580-475-10, 50580-475-11, 50580-475-50
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 6, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- Purpose
- Uses
-
Warnings
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
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
-
Directions
■ 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 yearsask a doctor - Other information
- Inactive ingredients
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
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 Cardswith
10 Individual Blisters
SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS
-
INGREDIENTS AND APPEARANCE
TYLENOL REGULAR STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-475 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POWDERED CELLULOSE (UNII: SMD1X3XO9M) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSES (UNII: 3NXW29V3WO) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape OVAL Size 16mm Flavor Imprint Code TYLENOL;325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-475-11 10 in 1 CARTON 08/30/2025 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-475-50 1 in 1 CARTON 08/30/2025 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:50580-475-10 1 in 1 CARTON 08/30/2025 3 1000 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/30/2025 Labeler - Kenvue Brands LLC (118772437)
