Label: MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable

  • 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 January 26, 2021

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  • SPL UNCLASSIFIED SECTION

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

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Meclizine HCl, USP 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    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.

  • 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
  • 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.

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

    •
    phenylketonurics: contains phenylalanine 0.28 mg per tablet
    •
    store at room temperature in a dry place
  • INACTIVE INGREDIENT

    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

    Questions? 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®.

  • PRINCIPAL DISPLAY PANEL

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Plus Pharma™

    Repackaged By: Preferred Pharmaceuticals Inc.

    NDC 68788-7850

    MECLIZINE HCl 25 mg

    ANTIEMETIC

    Treats and Prevents Motion Sickness

    Prevents nausea, dizziness and vomiting

    *Compare to the Active Ingredient in Bonine®

    Raspberry

    Natural & Artificial Flavor

    Contains no ingredient from a gluten-containing grain (wheat, barley, or rye).

    CHEWABLE TABLETS • 25 mg each

    Meclizine HCL 25mg Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7850(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:68788-7850-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
    2NDC:68788-7850-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33601/26/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-7850)
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