WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [WALGREEN CO.]

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WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [WALGREEN CO.]
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NDC 0363-1407-01, 0363-1407-02
Set ID f3116203-1b8f-438a-b779-7bdd90eaf79e
Category HUMAN OTC DRUG LABEL
Packager Walgreen Co.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) 
    Meclizine hydrochloride 25mg

  • PURPOSE

    Purpose
    Meclizine hydrochloride    Antiemetic

  • Uses• for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness

  • WARNINGS

    ​Warnings

    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:  take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician.

  • OTHER SAFETY INFORMATION

    Other information
    ■ store at 20-30°C (68-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide.

  • PRINCIPAL DISPLAY PANEL

    CartonCarton

  • PRINCIPAL DISPLAY PANEL

    PDP

  • PRINCIPAL DISPLAY PANEL

    Carton02Carton02

  • PRINCIPAL DISPLAY PANEL

    PDP02PDP02

  • INGREDIENTS AND APPEARANCE
    WAL-DRAM 2 QUICK-DISSOLVING 
    meclizine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1407
    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
    ERYTHRITOL (UNII: RA96B954X6)  
    MANNITOL (UNII: 3OWL53L36A)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code SJ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1407-012 in 1 CARTON03/01/2016
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-1407-023 in 1 CARTON10/23/2018
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/01/2016
    Labeler - Walgreen Co. (008965063)
    Registrant - Sato Pharmaceutical Co., Ltd. (690575642)
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