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

  • NDC Code(s): 51645-994-01, 51645-994-10
  • Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharma
  • 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 October 15, 2015

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  • 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

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  • 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 51645-994-01

    Plus Pharma

    Meclizine HCl 25 mg

    ANTIEMETIC

    Treats and Prevents Motion Sickness

    Prevents nausea, dizziness and vomiting

    *Compare to the Active Ingredient in Bonine®

    Raspberry

    100 CHEWABLE TABLETS

    25 mg each

    835028 Mec HCl 100 Drug ListNDC 51645-994-10

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    1000 CHEWABLE TABLETS

    25 mg each

    834884 Mec HCl 1000 Drug Listing

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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: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 (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (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:51645-994-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/15/2015
    2 NDC:51645-994-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/15/2015
    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 - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    Gemini Pharmaceuticals, Inc. 055942270 manufacture(51645-994)
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