ZEE UNASPIRIN ES (ACETAMINOPHEN) TABLET [ZEE MEDICAL INC]

ZEE UNASPIRIN ES (ACETAMINOPHEN) TABLET [ZEE MEDICAL INC]
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NDC 35418-210-02, 35418-210-67, 35418-210-68, 35418-210-69
Set ID 20e32e76-b019-4714-90a3-6dc178c7145a
Category HUMAN OTC DRUG LABEL
Packager Zee Medical Inc
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredient/TabletAcetaminophen 500mg

  • PURPOSE

    Purpose-Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Temporarily relieves pain dut to: headache, muscular aches, the common cold, minor pain of arthritis.  Temporarily reduces fever

  • DOSAGE & ADMINISTRATION

    Adults: Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

    Children under 12 years, ask a doctor


  • WARNINGS

    Liver Warning: This product contains acetaminophen. Severe liver damage
         may occur if you take:
    •    more than 8 tablets in 24 hours
    •    with other drugs containing acetaminophen (prescription or nonprescription).  Ask a doctor or pharmacist before using with other drugs if you are not sure.  
    •    3 or more alcoholic drinks every day while using this product
    ______________________________________________________________
    Do not use:
    •    with any other product containing acetaminophen this will provide more  
    than the recommended dose (overdose) of acetaminophen and could  
    cause serious health concerns.  
    •    for more than 10 days for pain unless directed by a doctor
    •    for more than 3 days for fever unless directed by a doctor
    •    When using this product do not exceed recommended dose.
    _______________________________________________________________
    Stop use and ask a doctor if:
    •    symptoms do not improve
    •    pain or fever persists or gets worse
    •    new symptoms occur
    •    redness or swelling is present

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
    get medical help or contact a Poison Control Center right away.  
    Prompt medical attention is critical for adults as well as for  
    children even if you do not notice any signs or symptoms.

  • INACTIVE INGREDIENT

    Inactive Ingredients: corn starch, microcrystalline cellulose,  
    povidone,  sodium starch glycolate, and stearic acid

  • PRINCIPAL DISPLAY PANEL

    ES Un-Aspirin, 250 Box

  • INGREDIENTS AND APPEARANCE
    ZEE UNASPIRIN  ES
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (FR1) Size12mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-210-69500 in 1 CARTON06/12/2012
    1NDC:35418-210-6850 in 1 CARTON
    1NDC:35418-210-67125 in 1 CARTON
    1NDC:35418-210-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Zee Medical Inc (009645623)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultratab Laboratories, Inc.151051757manufacture(35418-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(35418-210)

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