DENAGARD 80 COATED TYPE A MEDICATED ARTICLE- tiamulin fumarate powder

Denagard 80 coated Type A Medicated Article by

Drug Labeling and Warnings

Denagard 80 coated Type A Medicated Article 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

Coated (tiamulin hydrogen fumarate)

Type A Medicated Article

For the manufacture of Denagard 10

Type B Medicated Swine Feed only.

Not to be used for the manufacture of

Type C medicated feeds.

Active Ingredient:

tiamulin hydrogen fumarate:

80% w/w (363.2 g/lb.)

Inactive Ingredients:

porcine gelatin

Indications:

For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin; For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin.

Warnings:

Denagard 10 Type B Medicated Swine Feed label contains residue information for use in swine.

Keep out of reach of children.

lrritating to eyes and respiratory system.

May cause sensitization by inhalation and skin contact. Do not breathe dust.

Avoid contact with skin and eyes.

Wear suitable protective clothing and gloves.

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.

Storage:

Protect from light and moisture. Store at or below 25°C (77°F). Temporary excursions to 40°C (104°F) permitted.

Directions For Preparation of Denagard 10 Type B Medicated Swine Feed.

Ingredient:	Denagard 80%; Coated (tiamulin; hydrogen fumarate)	Rice Hulls	Mineral Oil
Quantity per 2000 lbs.:	56.2 lbs.*	1863.8 lbs.	80 lbs.

With mixer on, dispense mineral oil into rice hulls. Mix until sufficiently blended. Add Denagard 80% Coated (tiamulin hydrogen fumarate) to mixture while mixer is running. Mix until homogeneous.

* Includes 2% overage.

Restricted Drug (California):

Use only as directed.

For more information or to report adverse effects, call Elanco US Inc. at 1-800-428-4441.

For a complete listing of adverse reactions for DENAGARD reported to CVM see:

http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Manufactured for:
Elanco US Inc.
2500 Innovation Way
Greenfield, IN 46140
Product of Italy

Lot Number:

Date of Manufacture:

Date of Expiration:

Elanco, Denagard and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

NADA 139 – 472, Approved by FDA.

12/11

Elanco™

Principal Display Panel - 22 g in 1 kg Bag Label

Denagard 80%
Coated (tiamulin hydrogen fumarate)
Type A Medicated Article
Net Weight:
55 lb (25 kg)
Denagard® is a registered
trademark of Elanco US Inc.
NADA 139-472, Approved by FDA.
Product # 609413
NAH/DEN80-MA/TYPE A/BGL/1
12/11

INGREDIENTS AND APPEARANCE

DENAGARD 80 COATED TYPE A MEDICATED ARTICLE 
tiamulin fumarate powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 58198-9413
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

Inactive Ingredients
Ingredient Name	Strength
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-9413-1	25 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA139472	11/01/2015

Labeler - Elanco US Inc. (966985624)

Establishment
Name	Address	ID/FEI	Business Operations
Sandoz GmbH		301698247	API MANUFACTURE, MANUFACTURE