Denagard 80 coated Type A Medicated Article

Manufacturer
Elanco US Inc.
Effective date
2026-03-06
Label type
OTC ANIMAL DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 02:46:34

Label at a glance#

ProductDenagard 80 coated Type A Medicated Article
Active ingredientTiamulin Fumarate
Label structure7 sections

Storage and handling

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 Denaga...

Label contents#

Full prescribing information#

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:

OTC - ACTIVE INGREDIENT SECTION

tiamulin hydrogen fumarate:
80% w/w (363.2 g/lb.)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

porcine gelatin

Indications:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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:

STORAGE AND HANDLING SECTION

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.

Questions/Comments? For technical assistance or to report side effects, contact Elanco US Inc. at 1-800-428-4441. For additional information about reporting side effects for animal drugs, contact 1-888-FDA-VETS or www.fda.gov/reportanimalae.

Manufactured for:
Elanco US Inc.
Indianapolis, IN 46221

Product of Italy

Product of China

Denagard, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2025 Elanco or its affiliates

Approved by FDA under NADA # 139-472

YL243082X
YL243083X

Elanco™

Principal Display Panel - 22 g in 1 kg Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Denagard 80% Coated (tiamulin hydrogen fumarate) label
Denagard 80% Coated (tiamulin hydrogen fumarate) label

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

Denagard 80% Coated (tiamulin hydrogen fumarate) label
Denagard 80% Coated (tiamulin hydrogen fumarate) label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-9413-1Denagard 80 coated Type A Medicated Article25 kg in 1 BAGPOWDER2513

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TIAMULIN FUMARATEACTIVE INGREDIENTION1Q02ZCX4
TIAMULINACTIVE MOIETYE38WZ4U54R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-941358198-9413-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tiamulin FumarateION1Q02ZCXACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122025-11-21monthly-update2026-06-03 17:37:45

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.