TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-487-20, 50580-487-90
Set ID c019e048-167d-466f-896f-84144dd47f7e
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    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 capsules (3,250 mg) in 24 hours for adults or 5 capsules (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

    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

    adults and children 12 years and over
    • take 2 capsules every 4 to 6 hours while symptoms last
    • do not take more than 10 capsules 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 capsule every 4 to 6 hours while symptoms last
    • do not take more than 5 capsules in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 yearsask a doctor
  • Other information

    • each capsule contains: potassium 25 mg
    • store between 20-25°C (68-77°F). Avoid high humidity.
    • do not use if carton is opened or if foil inner seal imprinted with "TYLENOL" is broken or missing
  • Inactive ingredients

    ascorbyl palmitate, caprylic/capric triglycerides, dl-α-tocopherol, FD&C red no. 40, gelatin, glycerin, lecithin, medium chain triglycerides, mono-diglycerides, oleic acid, phosphatidylcholines (soya), polyethylene glycol, polyvinyl acetate phthalate, potassium acetate, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-487-20

    TYLENOL®

    Actual Size

    Acetaminophen

    Pain Reliever
    Fever Reducer

    Regular Strength

    Liquid Gels

    *Liquid-Filled Capsules

    20 Liquid Gels*
    325 mg each

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    TYLENOL   REGULAR STRENGTH
    acetaminophen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Inactive Ingredients
    Ingredient NameStrength
    ascorbyl palmitate (UNII: QN83US2B0N)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    .alpha.-tocopherol, dl- (UNII: 7QWA1RIO01)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    gelatin, unspecified (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    oleic acid (UNII: 2UMI9U37CP)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polyvinyl acetate phthalate (UNII: 58QVG85GW3)  
    potassium acetate (UNII: M911911U02)  
    povidone, unspecified (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code TY;325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-487-201 in 1 CARTON01/05/2016
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-487-901 in 1 CARTON01/05/2016
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/05/2016
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)