Label: MECLIZINE HYDROCHLORIDE- meclizine hcl tablet, chewable

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

Drug Label Information

Updated October 26, 2023

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  • Active ingredient (in each chewable tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • 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
    • breathing problems, such as emphysema or chronic bronchitis
    • difficulty urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • drowsiness may occur
    • avoid alcoholic beverages 
    • 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

    • do not exceed recommended dose
    • dosage should be taken one hour before travel starts
    • chew or crush tablets completely before swallowing;do not swallow tablets whole
    • adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by a doctor
  • 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

    corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

  • Questions or comments?

    1-800-540-3765

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-779
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRYImprint Code 44;404
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80136-779-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00911/01/2022
    Labeler - NORTHEAST PHARMA (081232935)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)
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