MOTION SICKNESS LESS DROWSY FORMULA (MECLIZINE HCL) TABLET [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]

MOTION SICKNESS LESS DROWSY FORMULA (MECLIZINE HCL) TABLET [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]
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NDC 50804-620-08
Set ID a3b8b125-e058-482c-8a02-5bc5bd957447
Category HUMAN OTC DRUG LABEL
Packager Good Sense (Geiss, Destin & Dunn, Inc.)
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    for prevention and treatment nausea, vomiting, or dizziness associated with motion sickness

  • Warnings

    Do not use

     for children under 12 years of age, unless directed by a doctor.

    Ask a doctor before use if you have

    • breathing problems such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children

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

  • Directions

    • To prevent motion sickness, the first dose should be taken 1 hour before starting activity
    • adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
    • do not exceed 2 tablets in 24 hours
  • Other information

    • store at room temperature 20o- 30o C (68o- 86o F)
  • Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, corn starch, D&C Yellow# 10 Aluminium lake, magnesium stearate, microcrystalline cellulose  sodium starch glycolate.

  • Questions or Comments?

    Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

  • Principal Display Panel

    Less Drowsy Formula

    MOTION SICKNESS II Tablets

    • Prevents up to 24 hours of Motion Sickness
    • Protection with less drowsiness

    Meclizine HCI, 25mg

    Antiemetic

    Tablets

    *Compare to active ingredient in Dramamine® Less Drowsy Formula

    *This product is not manufactured or distributed by Prestige Brand, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by: Geiss, Destin & Dunn, Inc.

    Peachtree city, GA 30269

    www.valuelabel.com

  • Product Label

    Meclizine HCI 25mg

    GoodSense Less Drowsy Formula Motion Sickness II

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS  LESS DROWSY FORMULA
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-620
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    Colorwhite, yellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL086
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-620-081 in 1 CARTON03/19/201212/31/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/19/201212/31/2023
    Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

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