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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 12, 2023

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

  • 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