CVS MOTION SICKNESS FAST MELTING (MECLIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC.]

CVS MOTION SICKNESS FAST MELTING (MECLIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC.]
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NDC 59779-534-01
Set ID 2a723bce-a581-4558-b028-22f1f9125dd5
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) 
    Meclizine hydrochloride 25mg

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  • PURPOSE

    Purpose
    Meclizine hydrochloride    Antiemetic

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    ​Warnings

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

    Ask a doctor before use if you have
    ■ glaucoma   ■ a breathing problem such as emphysema or chronic bronchitis
    ■ difficulty in urination due to enlargement of the prostate gland

    Ask a physician or pharmacist before use if you are
    ■ taking sedatives or tranquilizers

    When using this product
    ■ you may get drowsy   ■ avoid alcoholic beverages
    ■ be careful when driving a motor vehicle or operating machinery
    ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

    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.

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  • DOSAGE & ADMINISTRATION

    Directions
    To prevent motion sickness take it at least one hour before traveling    
    Adults and children 12 years of age and over:  take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician.

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  • OTHER SAFETY INFORMATION

    Other information
    ■ Store at 20-30°C (68-86°F)

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  • INACTIVE INGREDIENT

    Inactive ingredients
    acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide.

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  • INGREDIENTS AND APPEARANCE
    CVS MOTION SICKNESS FAST MELTING 
    meclizine hydrochloride tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-534
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ERYTHRITOL (UNII: RA96B954X6)  
    MANNITOL (UNII: 3OWL53L36A)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code SJ
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-534-01 1 in 1 CARTON
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 08/27/2015
    Labeler - CVS Pharmacy, Inc. (062312574)
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