Label: TYLENOL REGULAR STRENGTH- acetaminophen tablet

  • NDC Code(s): 50580-496-60
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 3, 2016

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


    Drug Facts

  • Active ingredient (in each tablet)

    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 tablets (3,250 mg) in 24 hours for adults or 5 tablets (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 you have liver disease

    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 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

    adults and children 12 years and over
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 10 tablets 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 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets 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 carton is opened or neck wrap or foil inner seal imprinted with "TYLENOL" is broken or missing
  • Inactive ingredients

    magnesium stearate, modified starch, powdered cellulose, pregelatinized starch, sodium starch glycolate

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


    NDC 50580-496-60


    Pain Reliever
    Fever Reducer

    Regular Strength

    Actual Size

    100 Tablets
    325 mg each

    Principal Display Panel
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-496
    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
    magnesium stearate (UNII: 70097M6I30)  
    powdered cellulose (UNII: SMD1X3XO9M)  
    sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code TYLENOL;325
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-496-60 1 in 1 CARTON 02/01/1999
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/01/1999
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)