PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC]

PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC]
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NDC 36800-770-12
Set ID ecd6df7e-e7e2-446b-85ef-25971281fe31
Category HUMAN OTC DRUG LABEL
Packager TopCo Associates LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each gelcap)

    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 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 years
    • ask a doctor
  • Other information

    • store between 20-25ºC (68-77ºF)
    • retain carton for complete product information
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    NDC 36800-770-02

    TopCare® Health™

    Compare to Extra Strength Tylenol® Rapid Release Gels Active Ingredient*

    Extra Strength

    Pain Relief

    Acetaminophen 500 mg

    Pain Reliever/Fever Reducer

    Rapid Release

    For Adults

    Pharmacists Recommend

    50 Gelcaps

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-770
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorgray (red and light blue ends) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-770-011 in 1 CARTON03/31/2014
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:36800-770-021 in 1 CARTON03/31/2014
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:36800-770-031 in 1 CARTON03/31/201408/31/2022
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:36800-770-051 in 1 CARTON03/31/201409/30/2022
    4225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:36800-770-12400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201603/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/31/2014
    Labeler - TopCo Associates LLC (006935977)

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