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 May 19, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

    Close
  • Purpose

    Antiemetic

    Close
  • Uses

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

    Close
  • 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 an enlargement of the prostate gland
    • a breathing problems such as emphysema or chronic bronchitis 

    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 professional before use.

    Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    Close
  • Directions

    • to prevent motion sickness, take the first dose one hour before starting activity
    • to prevent or treat motion sickness: 1 to 2 tablets once daily for adults and children 12 years and over, or as directed by a doctor 
    Close
  • Other information

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

    corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gel

    Close
  • Questions of comments?

    1-800-426-9391

    Close
  • Principal Display Panel

    CVP®
    Health

    COMPARE TO
    DRAMAMINE®
    LESS DROWSY FORMULA
    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 Prestige Brands, Inc., owner of the registered trademark
    Dramamine® Less Drowsy Formula.       50844        REV0715B40302

    Distributed by Salado Sales, Inc., P.O. Box 6115, Temple, Texas 76503    www.CVPproducts.com

    CVP 44-403

    CVP 44-403

    Close
  • INGREDIENTS AND APPEARANCE
    LESS DROWSY FORMULA MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-403
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code 44;403
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57243-403-02 1 in 1 PACKAGE 06/24/2002
    1 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 06/24/2002
    Labeler - Salado Sales, Inc. (009830555)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(57243-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(57243-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(57243-403)
    Close