MECLIZINE HCL 12.5 MG TABLET [ADVANCE PHARMACEUTICAL INC.]

MECLIZINE HCL 12.5 MG TABLET [ADVANCE PHARMACEUTICAL INC.]
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NDC 17714-117-01
Set ID 76efad7e-e765-430f-9232-63553d02f2c5
Category HUMAN OTC DRUG LABEL
Packager Advance Pharmaceutical Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Drug Facts

  • Active indredient (in each caplet)

    Meclizine HCL 12.5 mg

  • Purpose

    Antiemetic

  • Uses

    • prevents and treats nausea, vomiting, or dizziness due to motion sickness
    • for other uses, consult your doctor
  • Warnings

    Ask a docotor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged 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 tranquillizers 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.

  • ASK DOCTOR

    Ask a doctor before use if you have

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

    When using this prodcut

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives and tranqulizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • adults & children 12 years and over: 2-4 caplets once daily
    • children under 12 years: ask a doctor
  • Other information

    • each caplet contains: calcium 51 mg
    • store at room temperature 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • 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

  • PRINCIPAL DISPLAY PANEL

    NDC: 17714-117-01

    Meclizine 12.5mg caplets

    image description

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 12.5 MG 
    meclizine hcl 12.5 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code AP;117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-117-01100 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(17714-117)

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