Label: AIRMIT ACE- dimenhydrinate tablet

  • NDC Code(s): 49873-802-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 21, 2019

If you are a consumer or patient please visit this version.

  • 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 finalpart33603/11/2005
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-802) , label(49873-802) , pack(49873-802)