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

If you are a consumer or patient please visit this version.

  • 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

    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

    Ask a doctor before use if the user

    ■ 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.

    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.

    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

    ■ 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

  • Other information


    ■ store between 20-25°C (68-77°F)
    ■ do not use if blister unit is torn or broken

  • Inactive ingredients


    carnauba wax, hypromellose, magnesium stearate,powdered cellulose, pregelatinized starch, sodium starch glycolate

  • QUESTIONS

    Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • 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 Cards

    with

    10 Individual Blisters

    SMART PACKAGING
    DESIGNED FOR HEALTH
    CARE PROFESSIONALS

    tylenol-1

  • INGREDIENTS AND APPEARANCE
    TYLENOL  REGULAR STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code TYLENOL;325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-475-1110 in 1 CARTON08/30/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-475-501 in 1 CARTON08/30/2025
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50580-475-101 in 1 CARTON08/30/2025
    31000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/30/2025
    Labeler - Kenvue Brands LLC (118772437)