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 December 1, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient (in each chewable tablet)

    Meclizine HCl, USP 25 mg

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  • Purpose

    Antiemetic

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  • Uses

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

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  • Warnings
  • DO NOT USE

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

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  • 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
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  • ASK DOCTOR/PHARMACIST

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

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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • 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.
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  • Other information

    store at room temperature
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  • OTHER SAFETY INFORMATION

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

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  • Questions or comments?

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

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Plus Pharma, Commack, NY 11725

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

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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-755(NDC:51645-994)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink (Uncoated) Score 2 pieces
    Shape ROUND (Biconvex) Size 8mm
    Flavor RASPBERRY Imprint Code 21G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63187-755-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2016
    2 NDC:63187-755-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2016
    3 NDC:63187-755-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2016
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 10/15/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    Name Address ID/FEI Business Operations
    Proficient Rx LP 079502574 REPACK(63187-755)
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