PAIN RELIEF EXTRA STRENGTH EASY TO SWALLOW (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]

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  • PAIN RELIEF EXTRA STRENGTH EASY TO SWALLOW (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]

PAIN RELIEF EXTRA STRENGTH EASY TO SWALLOW (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]
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NDC 69168-353-24
Set ID 01d11093-e9d4-4786-91af-17060380d705
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient

    Acetaminophen 500 mg

  • Purpose

    Analgesic/Antipyretic

  • Uses

    temporary relief of minor aches and pains associated with common cold headache toothache
    muscular aches backache arthritis menstrual cramps and reduction of fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

    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

    symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare
    sensitivity reaction occurs You may report side effects to 1-888-952-0050

    If pregnant or breast-feeding

    ask a health professional before use

  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
    Do not exceed recommended dosage.

  • Directions

    Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

    Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

  • Inactive Ingredients

    carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol(PEG) 400, polyethylene glycol (PEG) 8000, povidone, pregelatinized starch, stearic acid, sucralose, titanium dioxide.

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Acetaminophen 500 mg EZ Tab\LB1093.jpg
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH EASY TO SWALLOW
    acetaminophen 500 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-353
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code TCL342
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-353-2424 in 1 CARTON; Type 0: Not a Combination Product12/17/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/17/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-353) , LABEL(69168-353) , MANUFACTURE(69168-353) , PACK(69168-353) , RELABEL(69168-353) , REPACK(69168-353)
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