Label: MECLIZINE HYDROCHLORIDE- meclizine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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  • Active ingredient (in each tablet)

    Meclizine HCI 25mg

  • Purpose

    Antiemetic

  • Uses

    For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

  • Warnings

    Do not use in children under 12 years of age unless directed by a doctor.

    Ask a doctor before use if you have

    • breathing problems, such as emphysema or chronic bronchitis

    • glaucoma

    • difficulty urinating due to an enlarged prostate gland

    A sk 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
    I f 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

    • take the first dose 1/2 hour to 1 hour before starting activity
    • Adults and children 12 years of age and over:

    Take 1 to 2 tablets once daily, or as directed by a doctor
    Do not exceed 2 tablets in 24 hours.

  • Other information

    • TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

    • store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

    • protect from humidity

  • Inactive ingredients

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

  • Questions or comments?

    1-800-540-3765

  • package label

    1

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-378
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80136-378-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00905/01/2022
    Labeler - NORTHEAST PHARMA (081232935)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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