Label: MOTION SICKNESS- meclizine hydrochloride tablet

  • 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 03/14

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

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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 you have

    • a breathing problem 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 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.

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  • 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
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  • Other information

    • store at room temperature 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-632-6900

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  • Principal Display Panel

    COMPARE TO the active ingredient of DRAMAMINE® LESS DROWSY FORMULA *See back label

    Provides up to 24 hours of motion sickness relief

    Motion Sickness II

    LESS DROWSY FORMULA

    Meclizine Hydrochloride 25 mg

    Antiemetic

    TABLETS

    Do not use if Tamper-Evident seal under bottle cap imprinted with "Sealed for your Protection" is broken or missing.

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

    *Dramamine® Less Drowsy Formula is a registered trademark of Prestige Brands, Inc. Prestige Brands, Inc. is not affiliated with The Kroger Co. or this product.

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  • Product Label

    Meclizine HCl 25 mg

    Kroger Motion Sickness II Tablets

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  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-620
    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
    ANHYDROUS LACTOSE  
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code TCL086
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-620-08 8 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 07/11/2010
    Labeler - The Kroger Co. (006999528)
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