Label: THIAMINE HYDROCHLORIDE injection

  • NDC Code(s): 11695-1234-5
  • Packager: Covetrus North America
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated December 12, 2023

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  • Recommended Use:

    For use as a supplemental source of thiamine in dogs, cats, and horses.

  • Each mL Contains:

    Thiamine Hydrochloride..........................500 mg

    Disodium Edetate..............................0.01% w/v

    Benzyle Alcohol (as preservative)..........1.5% v/v

    Water for Injection......................................q.s.

    pH adjusted with Hydrochloric acid or Sodium Hydroxide

  • Dosage:

    For intravenous or intramuscular use as determined by the veterinarian.

  • Warning:

    Anaphylactogenesis to parental thiamine has occurred. Administer slowly and with caution in doses over 0.10 mL (50mg)

  • STORAGE AND HANDLING

    Store at controlled temperatures between 15° and 30°C (59° - 86°F). 

  • SPL UNCLASSIFIED SECTION

    Reorder #002489

    Questions?

    (855) 724-346

    Covetrus North America

    400 Metro Place North

    Dublin, OH 43017

    covetrus.com

    Made in the USA

    AH-002489-02

    V-0347-04

    L6566-0220

    ISS: 0220

    REV: 0220

  • Principal Display Panel

    THIAMINE HYDROCHLORIDE

    500 mg/mL Injectable Sterile Solution

    For use in dogs, cats and horses

    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian

    FOR ANIMAL USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    100 mL (3.4 fl oz)

    Thiamine Hydrochloride

    Thiamine Hydrochloride

    Thiamine Hydrochloride

  • INGREDIENTS AND APPEARANCE
    THIAMINE HYDROCHLORIDE 
    thiamine hydrochloride injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-1234
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) .1 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) .015 mL  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-1234-5100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2000
    Labeler - Covetrus North America (603750329)
    Registrant - Sparhawk Laboratories, Inc. (147979082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082analysis, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Tianxin Pharmaceutical Co., Ltd.527410270api manufacture
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