EXCINOL ARTHRITIS (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]

EXCINOL ARTHRITIS (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]
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NDC 49638-103-30
Set ID cf25c8c1-057b-43e0-a040-b6361977ee24
Category HUMAN OTC DRUG LABEL
Packager America Medic & Science, LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Excinol Arthritis (Acetaminophen) 650 mg

    Drug Facts

  • Active Ingredient

    Acetaminophen 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • arthritis
    • headache
    • muscular aches
    • temporarily reduces fever
    • the common cold
    • toothache
    • backache
    • menstrual cramps
  • 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.
  • Do not use

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.
  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • STOP USE

    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 appear
    • redness or swelling is present

    These could be signs of a serious condition

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Overdose warning

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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).

    • take 2 caplets every 8 hours with water.
    • Swallow whole—do not crush, chew, split or dissolve.
    • Do not take more than 6 caplets in 24 hours.
    • Do not use for more than 10 days unless directed by a doctor.

    Children

    • Under 18 years of age ask a doctor.
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if neck wrap is broken or missing
    • see end panel for lot number and expiration date
  • Inactive ingredients

    • carnauba wax, corn starch, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
  • Questions or comments?

    call toll free 1-855-470-6722

  • Excinol Arthritis (Acetaminophen) 650 mg

    image description

  • INGREDIENTS AND APPEARANCE
    EXCINOL ARTHRITIS (ACETAMINOPHEN) 
    acetaminophen tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49638-103-301 in 1 CARTON01/17/2019
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/17/2019
    Labeler - America Medic & Science, LLC (071065464)
    Registrant - America Medic & Science, LLC (071065464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratories, Inc037052099manufacture(49638-103)

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