Label: MECLIZINE HCL 12.5 MG tablet

  • 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 February 23, 2022

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  • 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
  • ASK DOCTOR/PHARMACIST

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

  • 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)
    • This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
  • Inactive ingredients

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

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580

    www.reliable1labs.com

  • HOW SUPPLIED

    NDC: 71335-0615-1: 30 Tablets in a BOTTLE

    NDC: 71335-0615-2: 60 Tablets in a BOTTLE

    NDC: 71335-0615-3: 90 Tablets in a BOTTLE

    NDC: 71335-0615-4: 28 Tablets in a BOTTLE

    NDC: 71335-0615-5: 20 Tablets in a BOTTLE

    NDC: 71335-0615-6: 120 Tablets in a BOTTLE

    NDC: 71335-0615-7: 100 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Meclizine Hcl 12.5mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 12.5 MG 
    meclizine hcl 12.5 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0615(NDC:69618-027)
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code AP;117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0615-130 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    2NDC:71335-0615-260 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    3NDC:71335-0615-390 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    4NDC:71335-0615-428 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    5NDC:71335-0615-520 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    6NDC:71335-0615-6120 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    7NDC:71335-0615-7100 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33611/01/2015
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0615) , RELABEL(71335-0615)
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