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

  • PURPOSE

    Purpose
    Meclizine hydrochloride    Antiemetic

  • INDICATIONS & USAGE

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

  • ​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.

  • 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.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    Carton

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    CVS MOTION SICKNESS FAST MELTING 
    meclizine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-534
    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
    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
    ColoryellowScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code SJ
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-534-011 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/27/2015
    Labeler - CVS Pharmacy, Inc. (062312574)