Label: MECLIZINE HCL- meclizine hcl 25mg chewable tablets tablet, chewable

  • NDC Code(s): 54738-025-01, 54738-025-03
  • Packager: Richmond Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 30, 2017

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

  • 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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