Label: LESS DROWSY FORMULA MOTION SICKNESS RELIEF- meclizine hcl tablet

  • 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 October 6, 2022

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  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    for the 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

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

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

    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, take the first dose 1/2 hour to 1 hour before starting activity
    • to treat motion sickness, take at first signs of symptoms
    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • use by expiration date on package 
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    CVP®
    Health

    COMPARE TO
    DRAMAMINE®
    ALL DAY LESS DROWSY
    ACTIVE INGREDIENT*

    LESS DROWSY FORMULA
    MOTION SICKNESS
    RELIEF
    MECLIZINE HCl TABLETS 25 mg/ANTIEMETIC

    HELPS PREVENT NAUSEA & DIZZINESS
    DUE TO MOTION SICKNESS FOR
    UP TO 24 HOURS

    12 TABLETS

    ACTUAL SIZE

    TAMPER EVIDENT: Use Only if This Blister is Intact

    *This product is not manufactured or distributed
    by Medtech Products Inc., owner of the registered
    trademark Dramamine® All Day Less Drowsy.       

    50844        REV0219D40302

    Distributed by Consumer Value Products, Inc.
    P.O. Box 6115, Temple, Texas 76502   
    CVPproducts.com

    CVP 44-403 REV0219D

    CVP 44-403 REV0219D

  • INGREDIENTS AND APPEARANCE
    LESS DROWSY FORMULA MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-403
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-403-021 in 1 PACKAGE06/24/2002
    112 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33606/24/2002
    Labeler - Salado Sales, Inc. (009830555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(57243-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(57243-403) , pack(57243-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(57243-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(57243-403)
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