MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.]

MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.]
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NDC 54738-025-01, 54738-025-03
Set ID 98e3fe5a-73c6-4dcc-b397-cc6013beee43
Category HUMAN OTC DRUG LABEL
Packager Richmond Pharmaceuticals, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Active ingredient

    Meclizine Hydrochloride 25 mg

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  • Purpose

    Antiemetic

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  • Uses

    For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

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  • Warnings

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an elarged prostate gland

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

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increse drowsiness
    • be careful when driving a moor vehicle or operating machinery
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  • Directions

    take dose one hour before travel starts
    tablets can be chewed or swallowed whole with water

    adults & children 12 years and over:

    • take 1-2 tablets once daily

    children under 12 years:

    • ask a doctor
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  • Keep out of reach of children.

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

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  • OTHER INFORMATION

    Phenylketonurics:
    each tablet contains:
    phenylalanine 0.28 mg
    store at room temparature 15 - 30 °C

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  • Questions or Comments

    Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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  • Inactive ingredients

    Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

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  • Package/Label Principal Display Panel

    NDC :  54738-025-01- 100 CHEW TABS

    NDC : 54738-025-03- 1000 CHEW TABS

    image description

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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl 25mg chewable tablets tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-025
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color red Score 2 pieces
    Shape ROUND Size 8mm
    Flavor RASPBERRY Imprint Code AP;115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54738-025-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015
    2 NDC:54738-025-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 05/01/2015
    Labeler - Richmond Pharmaceuticals, Inc. (043569607)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 manufacture(54738-025)
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