Active Ingredient:

(tiamulin hydrogen fumarate): 10 g/lb

Ingredients:

roughage product, mineral oil

See reverse side for use directions, cautions and warnings.

NADA 139-472, Approved by FDA
Net Weight: 35 lb (15.9 kg)

Denagard® 10

(tiamulin)

Medicated Premix

Type A Medicated Article

For use in animals only.
Store in a dry place.

Indications	Directions	Amount of Denagard 10 Per Ton	Tiamulin hydrogen fumarate in Complete Feed Per Ton	Withdrawal Period (days)
For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin	Feed continuously as the sole ration for 14 days	20 lb	200 g	7
For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis	Feed continuously as the sole ration for not less than 10 days	3.5 lb	35 g	2
For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to Tiamulin	Feed continuously as the sole ration	3.5 lb	35 g	2

Warning:

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.

Restricted Drug (California): Use only as directed.

For more information or to report adverse effects, call 1-800-637-0281.

Denagard® is a registered trademark of Novartis AG.

Product #609425

NAH/DEN10-MP/BGL/5

Marketed by:
Novartis Animal Health US, Inc.
Greensboro, NC 27408 U.S.A.

Principal Display Panel

Denagard® 10 (tiamulin)
Medicated Premix
Type A Medicated Article
For manufacture of
medicated swine feed only
Active Ingredient: (tiamulin
hydrogen fumarate): 10 g/lb
Ingredients: roughage product,
mineral oil
See reverse side for use directions,
cautions and warnings.
NADA 139-472, Approved by FDA
Net Weight: 35 lb (15.9 kg)
NOVARTIS ANIMAL HEALTH

Principal Display Panel
Denagard® 10 (tiamulin)
Medicated Premix Type A Medicated Article
NADA 139-472, Approved by FDA
Net Weight: 35 lb (15.9 kg)
NOVARTIS ANIMAL HEALTH

DENAGARD 10
tiamulin powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:58198-0700
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TIAMULIN FUMARATE (TIAMULIN)	TIAMULIN FUMARATE	22 g in 1 kg

Packaging
#	Item Code	Package Description
1	NDC:58198-0700-1	15.9 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA139472	07/17/1987	10/09/2012

Labeler - Novartis Animal Health US, Inc. (966985624)

Revised: 10/2013

Document Id: 2544476c-62a6-41e0-a3c2-5871f37698ed

Set id: 530ad988-3d3d-48d9-b066-0f0b569571d1

Version: 9

Effective Time: 20131023

Novartis Animal Health US, Inc.