Label: THIAMINA HCI- thiamine hydrochloride injection

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

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Drug Label Information

Updated December 13, 2023

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  • Indications:

    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 and Administration:

    To be determined by the veterinarian. For intramuscular use.

  • Warning:

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

  • STORAGE AND HANDLING

    Store between 15º–30ºC (59º–86ºF) in a dark place.

  • SPL UNCLASSIFIED SECTION

    Manufactured by Sparhawk Laboratories, Lenexa, KS 66215

    for Neogen® Corporation

  • Principal Display Panel

    THIAMINE HCI

    Injection

    500 mg/mL

    Sterile Solution

    For animal use only.

    Keep out of reach of children.

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

    Thiamine Hydrochloride

  • INGREDIENTS AND APPEARANCE
    THIAMINA HCI 
    thiamine hydrochloride injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-057
    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:13985-057-02100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2011
    Labeler - MWI/VetOne (019926120)
    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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