TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]

TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]
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NDC 50090-0005-0
Set ID 1b4db77f-b254-4db5-8e98-d46850140a9b
Category HUMAN OTC DRUG LABEL
Packager A-S Medication Solutions
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 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
    • 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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 yearsask 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

    carnauba wax1, corn starch1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch1, polyethylene glycol1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide


    1
    contains one or more of these ingredients
  • Questions or comments?

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

  • HOW SUPPLIED

    Product: 50090-0005

    NDC: 50090-0005-0 24 TABLET, FILM COATED in a BOTTLE, PLASTIC

  • Acetaminophen

    Label Image
  • INGREDIENTS AND APPEARANCE
    TYLENOL EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0005(NDC:50580-449)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    aluminum oxide (UNII: LMI26O6933)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    powdered cellulose (UNII: SMD1X3XO9M)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    sodium starch glycolate type A potato (UNII: 5856J3G2A2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TYLENOL;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0005-01 in 1 CARTON11/28/2014
    1 24 in 1 BOTTLE, PLASTIC ; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/19/1984
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0005)

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