Tylan 100 (Tylosin Phosphate) Granule [Elanco Us Inc.] -

TYLAN 100 (TYLOSIN PHOSPHATE) GRANULE [ELANCO US INC.]
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NDC	58198-0099-1
Set ID	0cb546ce-5db1-47a7-85b0-b6800ecb3315
Category	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager	Elanco US Inc.
Generic Name
Product Class
Product Number
Application Number	NADA012491

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SPL UNCLASSIFIED SECTION

AF0099
BG102345X
Elanco™
Tylan™ 100

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 100 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.

Approved by FDA under NADA # 012-491

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

Manufactured For:

Elanco US Inc.

Greenfield, IN 46140, USA

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

AF0099
BG102345X

Elanco™

Tylan™ 100 Tylosin Phosphate

Directions for Use

Read All Directions Carefully Before Mixing and Feeding

Tylan 100 Type A Medicated Article

Net Weight 50 lbs (22.68 kg)

Do Not Feed Undiluted.

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

Active Drug Ingredient—Tylosin (as tylosin phosphate) . . . 100 g per lb
INACTIVE INGREDIENT

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 100 may be irritating to unprotected skin and eyes. When mixing and handling Tylan 100 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 (1.0 pound Tylan 100 per ton) of complete feed. Feed continuously as the sole ration.

For control of swine dysentery. Feed 100 g of tylosin per ton (1.0 pound Tylan 100 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (0.4 pound Tylan 100 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 (0.4 to 1.0 pounds of Tylan 100) 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 (1.0 pound Tylan 100 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (1.0 pound Tylan 100 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 (0.4 to 1.0 pounds of Tylan 100) 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 100 Per Ton Of Type C Feed	Tylosin Per Ton Of Type C Feed
	0.08 to 0.10 lbs	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 systems: 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

STORAGE AND HANDLING

Store at Room Temperature, 25°C (77°F). Avoid moisture.
Not to be used after the date printed on the bottom of the bag.
Principal Display Panel - 50 lbs Bag Label

Elanco™
Tylan™ 100™

Net Weight: 50 lbs
(22.68 kg)

Tylosin Phosphate

Type A Medicated Article

INGREDIENTS AND APPEARANCE

TYLAN 100
tylosin phosphate granule

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC:58198-0099
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
tylosin phosphate (UNII: NR75X12AFF) (tylosin - UNII:YEF4JXN031)	tylosin phosphate	100 g in .45 kg

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58198-0099-1	22.68 kg in 1 BAG

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

Labeler - Elanco US Inc. (966985624)

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

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

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