Label: MOTION SICKNESS II- meclizine hydrochloride tablet

  • NDC Code(s): 55301-403-21
  • Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/15

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

  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

    Close
  • Purpose

     Antiemetic

    Close
  • Uses

    • for prevention and treatment of these symptoms associated with motion sickness:
    • nausea
    • vomiting
    • dizziness 
    Close
  • 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 an 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 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 health professional before use.

    Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center right away.

    Close
  • 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 
    Close
  • Other information

    • 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
    Close
  • Inactive ingredients

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

    Close
  • Questions of comments?

    1-800-426-9391

    Close
  • Principal Display Panel

    exchange √ select

    Compare to The Active Ingredient of
    Dramamine® Less Drowsy Formula*

    Less Drowsy Formula
    Motion Sickness
    Meclizine HCl Tablets 25 mg / Antiemetic

    Helps prevent Nausea and Dizziness due to
    Motion Sickness for up to 24 hours

    16
    TABLETS

    Actual Size

     √ quality value

    *This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.
    50844        REV0712H40321

    "SATISFACTION GUARANTEED OR YOUR MONEY BACK"
    Manufactured For Your Military Exchanges
    Distributed by: LNK International, Inc.
    Hauppauge, NY 11788
    1-800-426-9391

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

    Exchange Select 44-403

    Exchange Select 44-403

    Close
  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS II 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55301-403
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    LACTOSE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;403
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55301-403-21 2 in 1 CARTON
    1 8 in 1 BLISTER PACK; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 06/24/2002
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55301-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55301-403)
    Close