Label: AIRMIT ACE- dimenhydrinate tablet

  • NDC Code(s): 49873-802-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 1, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Dimenhydrinate 25 mg

  • PURPOSE

    Purpose
    Antiemetic

  • INDICATIONS & USAGE

    Uses
    For the prevention and treatment of the following symptoms associated with motion sickness
    ■nausea  ■vomiting  ■dizziness

  • WARNINGS

    Warnings

    Do not use

    ■for children under 2 years of age unless directed by a doctor
    ■this product if you are taking sedatives or tranquilizers, without first consulting your doctor

    Ask a doctor before use if you have
    ■a breathing problem such as emphysema or chronic bronchitis
    ■glaucoma
    ■difficulty in urination due to enlargement of the prostate gland

    When using this product
    ■may cause marked drowsiness: alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    ■avoid alcoholic beverages
    ■use caution when driving a motor vehicle or operating machinery

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

    Keep our of reach of children.  In case of over dose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions


    adults and children 12 years of age and over - oral dosage is 2 to 4 tablets every 4 to 6 hours, not to exceed 16 tablets in 24 hours, or as directed by a doctor

    children 6 to under 12 years of age - oral dosage is 1 to 2 tablets every 6 to 8 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor

    children 2 to under 6 years of age - oral dosage is 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor

    children under 2 years of age - ask a doctor

  • OTHER SAFETY INFORMATION

    Other information
    ■each tablet contains: calcium 5mg

  • INACTIVE INGREDIENT

    Inactive ingredients  Dibasic calcium phosphate, FD and C Yellow No. 6, hydroxypropyl cellulose, hydroxypropyl starch, lactose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sugar.

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    AIRMIT ACE 
    dimenhydrinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code SATO;7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-802-011 in 1 CARTON03/11/2005
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00903/11/2005
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-802) , label(49873-802) , pack(49873-802)
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