MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]

MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]
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NDC 17714-115-01, 17714-115-10
Set ID ef43c413-90a0-4d33-90a7-a29db3cdfa92
Category HUMAN OTC DRUG LABEL
Packager Advance Pharmaceutical Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Active ingredient

    Meclizine Hydrochloride 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • 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
  • 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
  • Keep out of reach of children.

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

  • OTHER INFORMATION

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

  • Questions or Comments

    call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    Meclizine 115-01

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl 25mg chewable tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-115
    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
    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
    ColorredScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-115-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2013
    2NDC:17714-115-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/01/2013
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-115)

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