Label: MECLIZINE HYDROCHLORIDE- meclizine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 November 22, 2022

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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

    • to prevent motion sickness, take the first dose 1/2 to 1 hour before starting activity
    • not for frequent or prolonged use except on the advice of a doctor
    • Adults and children 12 years of age and over: Take 1-2 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 room temperature 15˚-30˚C (59˚-86˚F)

    • protect from humidity

  • Inactive ingredients

    D&C yellow # 10 lake, lactose, magnesium stearate, microcrystalline cellulose, silica

  • package label

    1

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-478
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code AM4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80136-478-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/01/202108/31/2023
    Labeler - NORTHEAST PHARMA (081232935)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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