MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]

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MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-480-15, 47682-480-33, 47682-480-99
Set ID db363f96-bd07-4980-a5a9-7c0b0fd6ba0c
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Meclizine Hydrochloride 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • Warnings

    Do not use

    • for children under 12 years of age unless directed by a doctor
    • for frequent or prolonged use except under the advice of a doctor

    Ask a doctor before use if you have

    • breathing problems such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    if you are

    • taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery

    Do not exceed recommended dosage.

    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 use more than directed
    • to prevent motion sickness, take the first dose one hour before starting activity

    Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

    Children under 12 years: Do not give to children under 12 years of age.

  • Other information

    • store at room temperature 59- 86º F (15-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow # 10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    1-800-634-7680

  • Medique Medi-Meclizine Label

    Medique ®

    Medi-Meclizine

    All Day Relief

    Alivio que Perdura Todo el Dia

    Pull to Open

    Tire Para Abrir

    For the Prevention and Treatment of Motion Sickness • Meclizine HCl 25mg

    Para la Prevencion y el Tratamiento del Mareo “Mal del Viajero” • Hidrochloruro de Meclizina 25mg

    100 Tablets

    (50 x 2)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Unitarias

    Medique Medi-Meclizine

  • INGREDIENTS AND APPEARANCE
    MEDIQUE MEDI-MECLIZINE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-480
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Coloryellow (yellow) Score2 pieces
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code TCL;086
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-480-3350 in 1 BOX09/01/201308/01/2022
    1NDC:47682-480-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-480-15500 in 1 BOX11/08/201808/01/2022
    2NDC:47682-480-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/01/201308/01/2022
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761repack(47682-480) , relabel(47682-480)
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