MOTION SICKNESS RELIEF LESS DROWSY (MECLIZINE HCL) TABLET [BETTER LIVING BRANDS, LLC]

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MOTION SICKNESS RELIEF LESS DROWSY (MECLIZINE HCL) TABLET [BETTER LIVING BRANDS, LLC]
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NDC 21130-778-02, 21130-778-22
Set ID eff22da8-63b2-47b7-8cfc-e8251029ee44
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • 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 enlargement of the prostate gland
    • a breathing problem 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.

  • Directions

    • to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity
    • to treat motion sickness, take at first signs of symptoms
    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from heat and humidity
    • use by expiration date on package
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Signature
    Care™

    Quality
    Guaranteed

    COMPARE TO
    Dramamine®
    All Day Less Drowsy
    active ingredient*

    NDC 21130-778-02

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

    Helps prevent Nausea, Vomiting and
    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
    Medtech Products Inc., distributors of Dramamine®
    All Day Less Drowsy.
    50844       REV0219C40302

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

    OUR PROMISE
    QUALITY & SATISFACTION
    100% GUARANTEED
    OR YOUR MONEY BACK.

    Signature Care 44-403

    Signature Care 44-403

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF  LESS DROWSY
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-778
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-778-224 in 1 PACKAGE06/24/200209/21/2017
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:21130-778-021 in 1 PACKAGE06/24/2002
    212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33606/24/2002
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-778)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(21130-778)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(21130-778)
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