ZENTRIP (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SATO PHARMACEUTICAL CO., LTD.]

ZENTRIP (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SATO PHARMACEUTICAL CO., LTD.]
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NDC 49873-803-01
Set ID bcd069ef-8f16-4dbb-8829-0f152d42687d
Category HUMAN OTC DRUG LABEL
Packager Sato Pharmaceutical Co., Ltd.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • ACTIVE INGREDIENT

    Active ingredient (in each strip)    
    Meclizine hydrochloride 25mg

  • PURPOSE

    Purpose  
    Meclizine hydrochloride    Antiemetic

  • INDICATIONS & USAGE

    Uses
    ■ For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

  • Warnings

    Enter section text here

    Do not use in children under 12 years of age unless directed by a physician

    Ask a doctor before use if you have

    ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis

    ■ difficulty in urination due to enlargement of the prostate gland

    Ask a physician or pharmacist before use if you are

    ■ taking sedatives or tranquilizers

    When using this product

    ■ you may get drowsy ■ avoid alcoholic beverages

    ■ be careful when driving a motor vehicle or operating machinery

    ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    To prevent motion sickness take it at least one hour before traveling    
    Adults and children 12 years of age and over:  Oral dosage is 1 to 2 strips (25 to 50 mg) to dissolve on tongue once daily, or as directed by a physician.

  • OTHER SAFETY INFORMATION

    Other information 
    ■ Store tightly closed, protected from light, at 20-30°C. (68-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    acesulfame potassium, , ferric oxide, hypromelloses, mannitol, menthol, orange oil, polyethylene glycol 400, sucralose, sucrose esters of fatty acids

  • PRINCIPAL DISPLAY PANEL

    carton






  • INGREDIENTS AND APPEARANCE
    ZENTRIP 
    meclizine hydrochloride film, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-803
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MANNITOL (UNII: 3OWL53L36A)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) (UNII: L98X941W2B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-803-018 in 1 CARTON02/03/2009
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/03/2009
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

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