Label: MOTION SICKNESS RELIEF- meclizine hcl tablet, film coated

  • NDC Code(s): 83059-0007-1
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each liquid-filled capsule)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • Warnings

    Do not usefor 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 n avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • do not take more than directed
    • take first dose ½ to 1 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

    • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from heat and humidity
  • Inactive ingredients

    colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

  • Questions or comments?

    1-800-373-6981 (toll-free)

  • SPL UNCLASSIFIED SECTION

    Shield Pharmaceuticals Corp.
    Carle Place, NY 11514

  • PRINCIPAL DISPLAY PANEL

    Compare to Dramamine® Less Drowsy active ingredient†

    LESS DROWSY FORMULA

    Motion Sickness Relief

    Meclizine HCl, 25 mg

    Antiemetic
    Helps prevent nausea and dizziness due to motion sickness

    For Ages 12 and Over

    Motion Sickness Label

    Motion Sickness Carton

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0007
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0007-11 in 1 PACKAGE12/06/2023
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00212/06/2023
    Labeler - Shield Pharmaceuticals Corp (118724924)