DENAGARD 10 - tiamulin fumarate powder 
Novartis Animal Health US, Inc.

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Denagard-Medicated Premix

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)

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 #700

NAH/DEN10-MP/BGL/4

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

Net Weight: 35 lb (15.9 kg)

NOVARTIS ANIMAL HEALTH

DENAGARD 10  tiamulin   powder

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58198-0700-1 15.9 kg In 1 BAG None

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

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

Revised: 03/2011Novartis Animal Health US, Inc.