MOTION SICKNESS II (MECLIZINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]

  • Home
  • MOTION SICKNESS II (MECLIZINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]

MOTION SICKNESS II (MECLIZINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]
PDF | XML
NDC 36800-620-08
Set ID 9b980e34-a0a5-4d33-9f23-d91b837d8edd
Category HUMAN OTC DRUG LABEL
Packager TOP CARE (Topco Associates LLC)
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
View All Sections
  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    for prevention and treatment of 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged 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 drinks
    • 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 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 and over: 1 to 2 tablets once daily, or as directed by a doctor
    • do not exceed 2 tablets in 24 hours
  • Other information

    • store between 20-25ºC (68-77ºF)
  • 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 toll free: 1-888-423-0139

  • Principal Display Panel

    COMPARE TO DRAMAMINE® LESS DROWSY FORMULA ACRIVE INGREDIENT*

    LESS DROWSY FORMULA

    Motion Sickness Relief

    MECLIZINE HCI, 25 mg - ANTIEMETIC

    LONG LASTING

    • Up to 24 Hours of Protection
    • Prevents Nausea, Dizziness and Vomiting

    TABLETS

    *This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Dramamine® Less Drowsy Formula.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL  60007

    topcare@topco.com

    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.

  • Product Label

    Meclizine HCI 25 mg

    TOPCARE HEALTH Motion Sickness Relief

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS II 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-620
    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)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL086
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-620-081 in 1 CARTON05/31/201312/30/2022
    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 FINALpart33605/31/201312/30/2022
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
View All Sections

Related Drugs

Search DailyMed Drugs