Label: LESS DROWSY MOTION SICKNESS RELIEF- meclizine hcl tablet

  • NDC Code(s): 11822-0775-3, 11822-0775-9
  • Packager: Rite Aid Corporation
  • 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 April 3, 2020

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

  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness:

  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis 

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery 

    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 (1-800-222-1222) right away.

  • Directions

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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gel

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    RITE
    AID®
    PHARMACY

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

    LESS DROWSY FORMULA
    motion sickness relief
    meclizine HCl 25 mg
    antiemetic 

    helps prevent nausea and dizziness due to
    motion sickness for up to 24 horus

    8 TABLETS

    ACTUAL
    SIZE

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

    *This product is not manufactured or distributed by
    Prestige Brands, Inc., owner of the registered trademark
    Dramamine® Less Drowsy Formula.
    50844         ORG071540319

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE
    CAMP HILL, PA 17011

    IF YOU’RE NOT
    SATISFIED, WE’LL
    HAPPILY REFUND
    YOUR MONEY.

    Rite Aid 44-403

    Rite Aid 44-403

  • INGREDIENTS AND APPEARANCE
    LESS DROWSY MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0775
    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
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0775-91 in 1 CARTON06/30/2019
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11822-0775-310 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product06/30/201906/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33606/30/2019
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(11822-0775)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(11822-0775)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(11822-0775)