Label: MOTION SICKNESS RELIEF LESS DROWSY- meclizine hcl tablet

  • NDC Code(s): 21130-778-02, 21130-778-22
  • Packager: Better Living Brands, LLC
  • 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 21, 2015

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

    • 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 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  (1-800-222-1222) right away.

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  • 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 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 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

    Signature
    Careā„¢
    Quality
    Guaranteed

    NDC 21130-778-02

    COMPARE TO Dramamine® Less Drowsy Formula active ingredient*

    Less Drowsy Formula
    Motion Sickness Relief
    Meclizine HCl 25 mg | Antiemetic

    Helps prevent Nausea and
    Dizziness due to Motion Sickness
    for up to 24 hours

    12 TABLETS

    TAMPER EVIDENT: Use Only if This Blister is Intact

    *This product is not manufactured or distributed by Prestige Brands, Inc., distributors of Dramamine® Less Drowsy Formula.
    50844      ORG071540302

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929

    www.betterlivingbrandsLLC.com

    Signature Care 44-403

    Signature Care 44-403

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  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF  LESS DROWSY
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-778
    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)  
    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; Type 0: Not a Combination Product
    2 NDC:21130-778-02 3 in 1 PACKAGE
    2 4 in 1 BLISTER PACK; 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 - Better Living Brands, LLC (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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