Label: DENAGARD 80 COATED TYPE A MEDICATED ARTICLE- tiamulin fumarate powder

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.

tiamulin hydrogen fumarate:

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

porcine gelatin

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.

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.

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

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:

www.fda.gov/reportanimalae

Manufactured for:
Elanco US Inc.
Greenfield, IN 46140 USA

Product of Italy

Lot Number:

Date of
Manufacture:

Date of
Expiration:

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

© 2023 Elanco or its affiliates

Approved by FDA under NADA # 139-472

YL240600X

Elanco™

Net Weight:
55 lb (25 kg)
Denagard™ 80%
Coated (tiamulin hydrogen fumarate)
Type A Medicated Article
Approved by FDA under NADA # 139-472