LESS DROWSY MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [FAMILY DOLLAR SERVICES INC]

LESS DROWSY MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [FAMILY DOLLAR SERVICES INC]
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NDC 55319-403-19
Set ID 46caca5e-e499-4ad1-8757-3e01c6a33bf0
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • 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 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.

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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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • see end flap for expiration date and lot number
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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

    FAMILY
    wellness™

    COMPARE TO THE ACTIVE INGREDIENT OF
    DRAMAMINE® LESS DROWSY FORMULA*

    Less Drowsy
    Motion Sickness Relief
    Meclizine HCl Tablets 25 mg/Antiemetic

    Helps Prevent Nausea and Dizziness
    Due to Motion Sickness for up to 24 Hours

    8 TABLETS

    ACTUAL SIZE

    OTC
    network

    100% satisfaction guaranteed or your money back

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

    *This product is not manufactured or distributed by
    Prestige Brands, Inc., owner of the registered trademark
    Dramamine® Less Drowsy Formula.
    50844        REV0715B40319

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC
    10611 MONROE RD, MATTHEWS, NC 28105

    Not 100% satisfied?
    Return package and unused product within 30 days to any
    Family Dollar store for a refund (with receipt) or exchange.

    Family Wellness 44-403

    Family Wellness 44-403

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  • INGREDIENTS AND APPEARANCE
    LESS DROWSY MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-403
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code 44;403
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-403-19 1 in 1 CARTON 06/24/2002
    1 8 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 - Family Dollar Services Inc (024472631)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55319-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55319-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(55319-403)
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