Label: NAUSX- meclizine hydrochloride tablet, chewable

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 19, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

    Active ingredient (in each chewable tablet)Purpose
    Meclizine HCL, USP 25 mgAntiemetic
  • INDICATIONS & USAGE

    Uses

    • for the prevention and relief of nausea, vomiting, dizziness and other symptoms associated with motion sickness and/or travelling
  • WARNINGS

    Warnings

    Do not use with any other product containing meclizine

    • ask a veterinarian before use if your dog has any chronic illnesses
    • ask a veterinarian or pharmacist if your dog is on any other medication before use
    • keep out of reach of children in case of overdose contact poison control center immediately
    • stop use and contact veterinarian if symptoms persist for more than 72 hours
    • do not use on dogs under 26 pounds
  • DOSAGE & ADMINISTRATION

    Directions

    • give one tablet 30 minutes prior to expected travel
    • effects last approximately 6 hours
    • DO NOT exceed two doses in 24 hours
    • for dogs 26 - 75 pounds only
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20 - 25 C (66 - 78 F)
    • protect from moisture
    • see end flap for expiration date and lot #
  • SPL UNCLASSIFIED SECTION

    Inactive Ingredients

    croscarmellose sodium, dicalcium phosphate dehydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid, aspertame, dextrose, fd&c red #40 lake, maltodextrin, natural and artificial flavors, sugar, tricalcium phosphate

  • SPL UNCLASSIFIED SECTION

    Questions or Comments

    800.981.7642
    petsotc.com

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Goldman Pharmaceutical Group Inc.
    Holbrook, NY 11741

    Tamper-evident : Do not use if carton is open or blister unit is broken or torn

    MADE IN AMERICA

  • PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton

    pet otc™
    over the counter

    NausX®
    (Meclizine HCl, USP 25 mg) Antiemetic

    PREVENTS
    AND RELIEVES:
    Dizziness
    Nausea
    Vomiting
    TREATS SYMPTOMS
    ON THE SPOT!

    26 - 75 lbs
    10
    CHEWABLE
    TABLETS

    MADE IN THE USA

    Recommended by veterinarians for
    motion sickness

    NDC 72087-012-10

    Principal Display Panel - 25 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    NAUSX 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:72087-012(NDC:0536-1018)
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SUCROSE (UNII: C151H8M554)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorPINK (pink) Score2 pieces
    ShapeROUND (biconvex tablet with bisect) Size8mm
    FlavorImprint Code 21G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72087-012-2010 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER03/01/2019
    Labeler - Goldman Pharmaceutical Group Inc (080389804)
    Registrant - Goldman Pharmaceutical Group, Inc. (080389804)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goldman Pharmaceutical Group, Inc.080389804REPACK
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