Label: MOTION SICKNESS RELIEF- meclizine hcl tablet, chewable

  • 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 November 28, 2017

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  • Active ingredient (in each tablet)

    Meclizine Hydrochloride 25 mg

  • Purpose

    Antiemetic

  • Uses

    for prevention and treatment of these symptoms associated with motion sickness:

    • nausea
    • vomiting
    • dizziness
  • Warnings

    Do not use

    for children under 12 years of age unless directed by a doctor

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • take first dose one hour before starting activity
    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • Other information

    • Phenylketonurics: each tablet contains: phenylalanine 0.28 mg
    • store at room temperature 15º - 30ºC (59º - 86ºF)
  • Inactive ingredients

    Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

  • Questions or comments?

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Motion Sickness Relief

    30 Tablets   15 Pouches (2 Tablets per Pouch)

    NDC 69842-395-54

    CVSF36-00

    CVSB36-00

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-395
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-395-5415 in 1 CARTON11/28/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33611/28/2017
    Labeler - CVS PHARMACY, INC. (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(69842-395)
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