TYLAN 40- tylosin phosphate granule

Tylan 40 by

Drug Labeling and Warnings

Tylan 40 by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Elanco Clinton Laboratories, Provimi North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

AF0040

Elanco™

Tylan™40

™

Net Weight: 50 lbs (22.68 kg)

Tylosin Phosphate

Type A Medicated Article

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

For use in Swine and Beef Cattle Feeds Only

Do Not Feed Undiluted

Equivalent to 40 g Tylosin per Pound

Swine:

For reduction in severity of effects of atrophic rhinitis.

For control of swine dysentery associated with Brachyspira hyodysenteriae.

For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with Tylan Soluble (tylosin) drinking water.

For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with Tylan Soluble (tylosin) in drinking water.

Beef Cattle:

For reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.

Restricted Drug (California), Use only as Directed.

NADA # 12-491, Approved by FDA

Elanco, Tylan and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

Manufactured For:

Elanco US Inc.

2500 Innovation Way,

Greenfield, IN 46140, USA

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

SPL UNCLASSIFIED SECTION

AF0040

Elanco™

Directions for Use

Read All Directions Carefully

Before Mixing and Feeding

Tylan™ 40 Type A Medicated Article

Do Not Feed Undiluted.

Net Weight: 50 lbs

(22.68 kg)

Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Active Drug Ingredient—Tylosin (as tylosin phosphate) . . . 40 g per Ib

SPL UNCLASSIFIED SECTION

Ingredients: Roughage products, calcium carbonate and mineral oil.

Caution: To ensure adequate mixing, an intermediate blending step should be used prior to manufacturing a complete feed. Do not use in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite.

WARNINGS

Warning: Tylan 40 may be irritating to unprotected skin and eyes. When mixing and handling Tylan 40 use protective clothing, impervious gloves and a dust respirator. In case of accidental eye exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seek medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

For reduction in severity of effects of atrophic rhinitis. Feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed. Feed continuously as the sole ration.

For control of swine dysentery. Feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (1 pound Tylan 40 per ton) of complete feed until pigs reach market weight.

For the treatment and control of swine dysentery. Feed 40 to 100 grams of tylosin (1.0 to 2.5 pounds of Tylan 40) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days.

For control of porcine proliferative enteropathies (PPE, ileitis). Feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (2.5 pounds Tylan 40 per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (1.0 to 2.5 pounds of Tylan 40) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylan.

NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.

Mixing and Feeding Directions for Beef Cattle Feeds; For reduction of incidence of liver abscesses in beef cattle associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.	Tylan 40 Per Ton Of Type C Feed	Tylosin Per Ton Of Type C Feed
	0.2 to 0.25 Ibs	8 to 10 g
	To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.; Feed continuously as the sole ration.
Mixing Directions for Liquid Type B Cattle Feeds	LIMITATIONS:
	pH must be between 4.5 and 6.0. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top.; Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air, or other agitation-type tank system: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top.; Agitate daily as described even when not used. Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture.

NOT FOR HUMAN USE

Store at Room Temperature, 25°C (77ºF). Avoid moisture.

Not to be used after the date printed on the bottom of the bag.

Principal Display Panel - Tylan 40 Bag Label

Elanco™

AF0040

Tylan™ 40

Net Weight: 50 lbs
(22.68 kg)

INGREDIENTS AND APPEARANCE

TYLAN 40 
tylosin phosphate granule

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 58198-0040
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tylosin phosphate (UNII: NR75X12AFF) (tylosin - UNII:YEF4JXN031)	tylosin phosphate	40 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
mineral oil (UNII: T5L8T28FGP)
rice bran (UNII: R60QEP13IC)
calcium carbonate (UNII: H0G9379FGK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-0040-1	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA012491	01/08/2010

Labeler - Elanco US Inc. (966985624)

Establishment
Name	Address	ID/FEI	Business Operations
Elanco Clinton Laboratories		039138631	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Provimi North America, Inc.		027859585	MANUFACTURE, LABEL, PACK