Label: MEDIQUE MEDI-MECLIZINE- meclizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 15, 2021

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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

  • HOW SUPPLIED

    Product: 50090-4493

    NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

  • MECLIZINE HYDROCHLORIDE

    Label Image
  • INGREDIENTS AND APPEARANCE
    MEDIQUE MEDI-MECLIZINE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4493(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)  
    MICROCRYSTALLINE CELLULOSE (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:50090-4493-0500 in 1 BOX08/30/2019
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/01/2013
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4493)
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