Label: CVS MOTION SICKNESS STRIPS- meclizine hydrochloride film, soluble

  • 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 February 20, 2019

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  • ACTIVE INGREDIENT

    Active ingredient (in each strip)    
    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 physician 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:  Oral dosage is 1 to 2 strips (25 to 50 mg) to dissolve on tongue once daily, or as directed by a physician.

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  • OTHER SAFETY INFORMATION

    Other information
    ■ Store tightly closed, protected from light, at 20-30°C. (68-86°F)

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  • INACTIVE INGREDIENT

    Inactive ingredients
    acesulfame potassium, ferric oxide, hypromelloses, mannitol, menthol, orange oil, polyethylene glycol 400, sucralose, sucrose esters of fatty acids

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  • INGREDIENTS AND APPEARANCE
    CVS MOTION SICKNESS STRIPS 
    meclizine hydrochloride film, soluble
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-288
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MANNITOL (UNII: 3OWL53L36A)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) (UNII: L98X941W2B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-288-01 8 in 1 CARTON 02/20/2019
    1 1 in 1 PACKET; 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 02/20/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - Tsukioka Film Pharma Co., Ltd. (693381774)
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