DENAGARD- tiamulin fumarate concentrate

Denagard by

Drug Labeling and Warnings

Denagard by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Type B Medicated

Swine Feed

For Manufacture of Type C medicated swine feed only.

Do not feed undiluted.

INDICATIONS & USAGE

Indications	Amount of Type B; Medicated Feed; Per Ton of Feed	Tiamulin hydrogen; fumarate in; Complete Type C; Medicated; Feed Per Ton	Withdrawal; Period; (days)
For treatment of swine dysentery associated; with Brachyspira; (formerly Serpulina; or Treponema); hyodysenteriae; susceptible to; Tiamulin	20 lb	200 g	7
For control of porcine proliferative; enteropathies (ileitis); associated with; Lawsonia intracellularis	3.5 lb	35 g	2
For control of swine dysentery associated; with Brachyspira; (formerly Serpulina; or Treponema); hyodysenteriae; susceptible to; Tiamulin	3.5 lb	35 g	2

Warnings:

Observe withdrawal time shown in table above.

Keep out of reach of children. Avoid contact with skin. Direct contact with skin or mucous membranes may cause irritation.

Caution:

Do not feed undiluted. Do not use in feeds for animals other than swine. The effects of tiamulin on swine reproductive performance, pregnancy and lactation have not been determined. Swine being treated with Denagard (tiamulin) should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin and semduramicin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

MIXING DIRECTIONS

Mix this medicated feed (Type B) with non-medicated feed ingredients to make a Type C medicated feed as follows:

Type C Medicated Feed Tiamulin grams/ton Feed	Pounds Medicated Feed (Type B)	Pounds Non-medicated Feed*
35	3.5	1996.5
200	20	1980

*When making an approved Type C medicated feed drug combination, the inclusion rate of this non-medicated feed should be adjusted for the amount of the other drug added to make such combination Type C medicated feed.

Storage:

Store at or below 25°C (77°F). Temporary excursions to 40°C (104°F) permitted.

To report adverse effects, access medical information, or obtain additional product information call 1-800-428-4441

For a complete listing of adverse reactions for DENAGARD reported to CVM see: www.fda.gov/reportanimalae

Denagard, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

Restricted Drug (California): Use only as directed.

Approved by FDA under NADA # 139-472

Marketed by:

Elanco US, Inc.

Greenfield, IN 46140

Elanco™

BG101792X

Principal Display Panel – Bag Label

Denagard™ 10

(tiamulin hydrogen fumarate)

Type B Medicated

Swine Feed

INGREDIENTS AND APPEARANCE

DENAGARD 
tiamulin fumarate concentrate

Product Information
Product Type	OTC TYPE B MEDICATED FEED ANIMAL DRUG	Item Code (Source)	NDC: 58198-7400
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tiamulin fumarate (UNII: ION1Q02ZCX) (TIAMULIN - UNII:E38WZ4U54R)	tiamulin fumarate	22 g  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-7400-1	15.9 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA139472	11/26/2001

Labeler - Elanco US Inc. (966985624)