Label: PHYSICIANSCARE MOTION SICKNESS- meclizine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings

    Do not use for children under 12 years of age unless directed by a doctor.

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ difficulty in urination due to enlargement of the prostate gland

    ■ glaucoma

    ■ a breathing problems such as emphysema or chronic bronchitis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    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

  • 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

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

  • DOSAGE & ADMINISTRATION

    Directions

    ■ to prevent motion sickness, take the 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 older) 1 to 2 tablets once daily, or as directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.

  • OTHER SAFETY INFORMATION

    Other information

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

    ■ store at 77°F (25°C); excursions permitted between 59- 86º F (15-30ºC)

    ■ protect from heat and humidity

    ■ use by expiration date on packet

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments? 1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    label imagelabel image

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE MOTION SICKNESS 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1008(NDC:47682-481)
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-1008-002 in 1 PACKET; Type 0: Not a Combination Product06/18/2021
    2NDC:0924-1008-026 in 1 BAG06/18/2021
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00906/18/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-1008) , repack(0924-1008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-1008) , repack(0924-1008)