Label: MOTION SICKNESS- meclizine hcl tablet

  • NDC Code(s): 70677-1088-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 15, 2023

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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

    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma
    • 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 right away.

  • Directions

    • do not take more than directed
    • take first dose ½ to 1 hour before starting activity
    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • Other information

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

    colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions or comments?

    Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

  • Principal display panel

    NDC 70677-1088-1

    Foster & Thrive™

    COMPARE TO
    DRAMAMINE® LESS DROWSY
    ACTIVE INGREDIENT*

    LESS DROWSY FORMULA
    Motion Sickness
    Meclizine HCl 25 mg
    ANTIEMETIC

    Ages 12 Years and Over

    Helps prevent:
    • Nausea • Vomiting • Dizziness
    due to Motion Sickness for up to 24 hours

    ACTUAL SIZE

    8 TABLETS

    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 Medtech Products Inc.,
    owner of the registered trademark
    Dramamine® Less Drowsy.
    50844      ORG042340319

    Rev. 05/23

    ©2023 McKesson Corporation

    Distributed by: McKesson Corp.,
    via Strategic Sourcing Services LLC.
    Memphis, TN 38141
    Money Back Guarantee
    www.fosterandthrive.com

    Foster and Thrive 44-403A

    Foster and Thrive 44-403A

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1088
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1088-11 in 1 CARTON04/06/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00904/06/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70677-1088)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(70677-1088) , pack(70677-1088)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70677-1088)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(70677-1088)
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