CVS MOTION SICKNESS STRIPS (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [CVS PHARMACY]

CVS MOTION SICKNESS STRIPS (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [CVS PHARMACY]
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NDC 69842-288-01
Set ID 59af9142-1ade-4c67-b0fe-f9ceeafba3ad
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • 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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