MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [PROFICIENT RX LP]

  • Home
  • MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [PROFICIENT RX LP]

MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [PROFICIENT RX LP]
PDF | XML
NDC 63187-755-30, 63187-755-60, 63187-755-90
Set ID e3499822-3e3f-43a3-b48d-4436f6cad8a3
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
View All Sections
  • Active ingredient (in each chewable tablet)

    Meclizine HCl, USP 25 mg

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting or dizziness due to motion sickness

  • Warnings

  • DO NOT USE

    Do not use in children under 12 years of age unless directed by a doctor.

  • 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.

  • 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 the poison control center immediately.

  • Directions

    •
    Dosage should be taken one hour before travel starts.
    •
    Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
    •
    Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.
  • Other information

    •
    store at room temperature
  • OTHER SAFETY INFORMATION

    •
    Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
    •
    Do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

  • Questions or comments?

    If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Plus Pharma, Commack, NY 11725

    *Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

  • WHEN USING

    When using this product

    •
    may cause drowsiness
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    avoid alcoholic drinks
    •
    use caution when driving a motor vehicle or operating machinery
  • PRINCIPAL DISPLAY PANEL

    NDC 63187-755-30

    Plus Pharma

    Repackaged by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    Meclizine HCl 25 mg

    ANTIEMETIC

    Treats and Prevents Motion Sickness

    Prevents nausea, dizziness and vomiting

    *Compare to the Active Ingredient in Bonine®

    Raspberry

    30 CHEWABLE TABLETS

    25 mg each

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    CHEWABLE TABLETS

    25 mg each

    63187-755-303
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-755(NDC:51645-994)
    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)  
    SUCROSE (UNII: C151H8M554)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    Colorpink (Uncoated) Score2 pieces
    ShapeROUND (Biconvex) Size8mm
    FlavorRASPBERRYImprint Code 21G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-755-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2016
    2NDC:63187-755-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2016
    3NDC:63187-755-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33610/15/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-755)
View All Sections

Related Drugs

Search DailyMed Drugs