Label: MECLIZINE HCL 25 MG- meclizine hcl tablet

  • NDC Code(s): 71335-1607-0, 71335-1607-1, 71335-1607-2, 71335-1607-3, view more
    71335-1607-4, 71335-1607-5, 71335-1607-6, 71335-1607-7, 71335-1607-8, 71335-1607-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 69618-028
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 20, 2024

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  • Drug Facts

  • Active ingredient (in each tablet)

    Meclizine HCL 25 mg

  • Purpose

    Antiemetic

  • Uses

    • prevents and treats nausea, vomiting or dizziness due to motion sickness
    • for others 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 enlarged prostate gland

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

    When using this prodcut

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers 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 product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers 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

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

    adults & children 12 years and over: 1-2 tablets once daily

    children unser 12 years: ask a doctor

  • Other information

    • Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
  • Inactive ingredients

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

  • 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

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

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

    www.reliable1labs.com

  • HOW SUPPLIED

    NDC: 71335-1607-1: 30 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-2: 20 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-3: 25 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-4: 40 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-5: 60 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-6: 90 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-7: 8 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-8: 14 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-9: 10 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-1607-0: 120 Tablets in a BOTTLE, PLASTIC

  • PRINCIPAL DISPLAY PANEL

    Meclizine 25 mg Chewable

    Label
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1607(NDC:69618-028)
    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
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    RASPBERRY (UNII: 4N14V5R27W)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SUCROSE (UNII: C151H8M554)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Colorpink (Light Raspberry color) Score2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1607-130 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
    2NDC:71335-1607-220 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    3NDC:71335-1607-325 in 1 BOTTLE; Type 0: Not a Combination Product09/10/2021
    4NDC:71335-1607-440 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    5NDC:71335-1607-560 in 1 BOTTLE; Type 0: Not a Combination Product02/03/2022
    6NDC:71335-1607-690 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2020
    7NDC:71335-1607-78 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    8NDC:71335-1607-814 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    9NDC:71335-1607-910 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2021
    10NDC:71335-1607-0120 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart33611/01/2015
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1607) , RELABEL(71335-1607)
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