Label: LESS DROWSY MOTION SICKNESS RELIEF- meclizine hydrochloride tablet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

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  • Purpose

     Antiemetic

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  • Uses

    • for prevention and treatment of these symptoms associated with motion sickness:
    • nausea
    • vomiting
    • dizziness 
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  • Warnings

    Do not use

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

    Ask a doctor before use if

    • 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 tranqulizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful 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.

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  • Directions

    • to prevent motion sickness, take the fitst 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 
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  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • used by expiration date on package 
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  • Inactive ingredients

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

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  • Questions of comments?

     1-800-426-9391

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  • Principal Display Panel

    NDC 21130-778-22

    Compare to Dramamine® Less Drowsy active ingredient*

    Less Drowsy Formula
    Motion Sickness Relief
    Meclizine HCl, 25 mg / Antiemetic
    •Helps Prevent Nausea and Dizziness Due to Motion Sickness

    32 TABLETS

    SAFEWAY™

    50844     REV1011D40327

    DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99, PLEASANTON, CA 94566-009

    QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK
    1-888-SAFEWAY / www.safeway.com

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

    Safeway 44-403

    Safeway 44-403

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  • INGREDIENTS AND APPEARANCE
    LESS DROWSY MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-778
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    LACTOSE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;403
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-778-22 1 in 1 CARTON
    1 32 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 06/24/2002
    Labeler - Safeway (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-778)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-778)
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