Label: LESS DROWSY MOTION SICKNESS RELIEF- meclizine hydrochloride 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 December 1, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Meclizine HCI 25 mg

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  • Purpose

    Antiemetic

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  • Uses

    • prevents and treats 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  urinating due to an enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking

    • sedatives
    • tranquilizers

    When using this product

    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center.

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  • Directions

    • take first dose one hour before starting activity

    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

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  • Inactive ingredients

    calcium stearate, FD&C red #40 aluminum lake, lactose, microcrystalline cellulose, silicon dioxide, Sodium starch glycolate

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  • Other Information

    • store at room temperature between 59º - 86ºF (15 - 30ºC)
    • protect from excessive moisture.
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  • PRINCIPAL DISPLAY PANEL

    Compare to Dramamine® LESS DROWSY FORMULA active ingredients*

    DISCOUNT drug mart FOOD FAIR

    less drowsy

    motion sickness relief tabs

    Meclizine Hydrochloride

    • antiemetic

    provides Up To 24 Hours of Motion Sickness Protection

    prevents nausea, dizziness, vomiting


    8 TABLETS (25 mg EACH)                      new smaller size

    Retain carton for complete product information.

    Distributed by: Drug Mart-Food Fair

    211 Commerce Dr., Medina, Ohio 44256

    Questions?: 866-467-2748

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  • INGREDIENTS AND APPEARANCE
    LESS DROWSY MOTION SICKNESS RELIEF 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-826
    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
    CALCIUM STEARATE (UNII: 776XM7047L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color pink Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code 25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53943-826-29 8 in 1 BLISTER PACK
    1 1 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 12/01/2014
    Labeler - Discount Drug Mart (047741335)
    Establishment
    Name Address ID/FEI Business Operations
    Bell Pharmaceuticals, Inc. 140653770 MANUFACTURE(53943-826)
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