Label: MECLIZINE HYDROCHLORIDE tablet

  • NDC Code(s): 69842-857-05, 69842-857-09
  • Packager: CVS Pharmacy, Inc
  • 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 December 11, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient (in each tablet)
    Meclizine HCl 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • Uses

    for prevention and treatment of these symptoms associated with motion sickness:
    ■ nausea ■ vomiting ■ dizziness

  • WARNINGS

    Do not give to

    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

    ■ To prevent motion sickness, take first dose ½ hour to 1 hour before starting activity
    ■ To treat motion sickness, take at first signs of symptoms
    Adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

  • Other information

    store at room temperature 20°–25°C (68°–77°F)

  • INACTIVE INGREDIENT

    corn starch, colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose

  • QUESTIONS

    Questions? 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2020 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS V-30287

    *This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.

  • PRINCIPAL DISPLAY PANEL

    CVSHealth

    Compare to the active ingredient in Dramamine® Less Drowsy Formula*

    Motion Sickness
    Less Drowsy Formula

    MECLIZINE HYDROCHLORIDE TABLETS
    Antiemetic

    Prevents up to 24 hours of
    motion sickness
    • Protection with less drowsiness
    • Prevents nausea, vomiting
    & dizziness

    16 TABLETS (25 mg EACH)

    CVS Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-857
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 5655
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-857-052 in 1 CARTON10/28/2020
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-857-091 in 1 CARTON08/13/2020
    28 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/13/2020
    Labeler - CVS Pharmacy, Inc (062312574)