MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SUPERVALU INC.]

MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SUPERVALU INC.]
PDF | XML

NDC 41163-304-02
Set ID 108bb943-529f-4510-b770-b54eca493ae0
Category HUMAN OTC DRUG LABEL
Packager SUPERVALU INC.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • 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 right away.

  • Directions

    • to prevent motion sickness, take the first dose 1/2 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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?

    1-855-423-2630

  • Principal Display Panel

    EQUALINE®

    compare to Dramamine®
    All Day Less Drowsy

    active ingredient*

    NDC 41163-304-02

    motion sickness relief
    meclizine HCl 25 mg
    (antiemetic)

    less drowsy formula

    helps prevent nausea & dizziness
    due to motion sickness
    for up to 24 hours

    12 tablets 

    TAMPER EVIDENT:
    USE ONLY IF THIS BLISTER IS INTACT

    actual size

    DOES NOT CONTAIN GLUTEN

     *This product is not manufactured or distributed by
    Medtech Products Inc., owner of the registered
    trademark Dramamine® All Day Less Drowsy.

    50844        REV0219D40302

    100% Quality
    GUARANTEED

    DISTRIBUTED BY UNFI
    PROVIDENCE, RI 02908 USA
    855-423-2630

    Equaline 44-403 REV0219D

    Equaline 44-403 REV0219D


  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-304
    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:41163-304-021 in 1 PACKAGE06/24/2002
    112 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 - SUPERVALU INC. (006961411)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(41163-304)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(41163-304)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(41163-304)