Label: CVS MOTION SICKNESS FAST MELTING- meclizine hydrochloride tablet, orally disintegrating

  • 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 August 27, 2015

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  • 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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