THIAMINA HCI- thiamine hydrochloride injection

Thiamina HCI by

Drug Labeling and Warnings

Thiamina HCI by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Sparhawk Laboratories, Inc., Jiangxi Tianxin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THIAMINA HCI 
thiamine hydrochloride injection

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-057
Route of Administration	INTRAVENOUS, INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	500 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)	.1 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	.015 mL  in 1 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-057-02	100 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2011

Labeler - MWI/VetOne (019926120)

Registrant - Sparhawk Laboratories, Inc. (147979082)

Establishment
Name	Address	ID/FEI	Business Operations
Sparhawk Laboratories, Inc.		147979082	analysis, manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Tianxin Pharmaceutical Co., Ltd.		527410270	api manufacture