Denagard

Manufacturer
Elanco US Inc.
Effective date
2019-12-11
Label type
OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:42:14

Label at a glance#

ProductDenagard
Active ingredienttiamulin fumarate
Label structure6 sections

Dosage and administration

Mix this medicated feed (Type B) with non-medicated feed ingredients to make a Type C medicated feed as follows: Type C Medicated Feed Tiamulin grams/ton Feed Pounds Medicated Feed (Type B) Pounds Non-medicated Feed* 35 3.5 1996.5 200 20 1980 *When making an approved Type C medicated feed drug combination, the inclusion rate of this non-medicated feed should be adjusted for the amount of the other drug added to ma...

Storage and handling

Store at or below 25°C (77°F). Temporary excursions to 40°C (104°F) permitted. To report adverse effects, access medical information, or obtain additional product information call 1-800-428-4441 For a complete listing of adverse reactions for DENAGARD reported to CVM see: www.fda.gov/reportanimalae Denagard, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Restricted Drug (California): ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Type B Medicated

Swine Feed

For Manufacture of Type C medicated swine feed only.

Do not feed undiluted.

INDICATIONS & USAGE SECTION

IndicationsAmount of Type B
Medicated Feed
Per Ton of Feed
Tiamulin hydrogen
fumarate in
Complete Type C
Medicated
Feed Per Ton
Withdrawal
Period
(days)
For treatment of swine dysentery associated
with Brachyspira
(formerly Serpulina
or Treponema)
hyodysenteriae
susceptible to
Tiamulin
20 lb 200 g 7
For control of porcine proliferative
enteropathies (ileitis)
associated with
Lawsonia intracellularis
3.5 lb 35 g 2
For control of swine dysentery associated
with Brachyspira
(formerly Serpulina
or Treponema)
hyodysenteriae
susceptible to
Tiamulin
3.5 lb 35 g 2

Warnings:

WARNINGS SECTION

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.

MIXING DIRECTIONS

SPL UNCLASSIFIED SECTION

Mix this medicated feed (Type B) with non-medicated feed ingredients to make a Type C medicated feed as follows:

Type C Medicated Feed Tiamulin grams/ton Feed Pounds Medicated Feed (Type B) Pounds Non-medicated Feed*
35 3.5 1996.5
200 20 1980

*When making an approved Type C medicated feed drug combination, the inclusion rate of this non-medicated feed should be adjusted for the amount of the other drug added to make such combination Type C medicated feed.

Storage:

STORAGE AND HANDLING SECTION

Store at or below 25°C (77°F). Temporary excursions to 40°C (104°F) permitted.

To report adverse effects, access medical information, or obtain additional product information call 1-800-428-4441

For a complete listing of adverse reactions for DENAGARD reported to CVM see: www.fda.gov/reportanimalae

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

Restricted Drug (California): Use only as directed.

Approved by FDA under NADA # 139-472

Marketed by:

Elanco US, Inc.

Greenfield, IN 46140

Elanco™

BG101792X

Principal Display Panel – Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Denagard™ 10

(tiamulin hydrogen fumarate)

Type B Medicated

Swine Feed

Principal Display Panel – Bag Label
Principal Display Panel – Bag Label

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
58198-740058198-7400-1

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

Reported adverse events (FAERS/openFDA)#

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