MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [CHAIN DRUG CONSORTIUM, LLC]

MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-778-02
Set ID 61d29808-e2c0-7f9b-e053-2991aa0a4682
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Active ingredient (in each tablet)

    Meclizine HCI 25mg

  • Purpose

    Antiemetic

  • Uses

    For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

  • Warnings

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

    Ask a doctor before use if you have

    • breathing problems, such as emphysema or chronic bronchitis

    • glaucoma

    • difficulty urinating due to an enlarged prostate gland

    A sk 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
    I f 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.

  • Directions

    • to prevent motion sickness, take the first dose one hour before starting activity
    • not for frequent or prolonged use except on the advice of a doctor
    • do not exceed recommended dose
    Adults and children 12
    years if age and older
    Take 1-2 tablets once daily, or as directed by a doctor.
    Do not exceed 2 tablets in 24 hours.

  • Other information

    TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

    • store at room temperature 15˚-30˚C (59˚-86˚F)

    • protect from humidity

  • Inactive ingredients

    croscarmellose sodium, D and C yellow no. 10 lake, lactose, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate, starch, stearic acid

  • package label

    778

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-778
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL086
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-778-021 in 1 CARTON07/01/2011
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/01/2011
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)

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