TYLAN 40 SULFA-G- tylosin phosphate and sulfamethazine granule

Tylan 40 Sulfa-G by

Drug Labeling and Warnings

Tylan 40 Sulfa-G by is a Animal medication manufactured, distributed, or labeled by Elanco, Elanco Animal Health, a Division of Eli Lilly and Company, Provimi North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

AF0904
Elanco™
Tylan™40 Sulfa-G™

Net Weight 50 lbs (22.68 kg)

Tylosin Phosphate and Sulfamethazine Elliptical Pellets

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 Feeds Only

Do not feed undiluted.

Equivalent to 40 g tylosin per pound and 40 g sulfamethazine per pound.

For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci.

Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.

Restricted Drug (California) - Use only as directed.

NADA 041-275, Approved by the FDA.

Manufactured for:

Elanco US Inc.

2500 Innovation Way

Greenfield, IN 46140, USA

QUESTIONS

Questions or Comments Call 1-800-428-4441

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

BG091003AMX

SPL UNCLASSIFIED SECTION

AF0904

Elanco™

Tylan™ 40 Sulfa-G™

Tylosin Phosphate and Sulfamethazine Elliptical Pellets

Net Weight 50 lbs (22.68 kg)

Type A Medicated Article

For Use in Swine Feeds Only

Do not feed undiluted.

Active Drug Ingredients:

Tylosin (as tylosin phosphate) ................................40 g per lb

Sulfamethazine...................................................... 8.8% (40 g per lb)

SPL UNCLASSIFIED SECTION

Ingredients: Roughage products, calcium carbonate, and mineral oil.

Caution: Do not use in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite.

WARNINGS

Warning: Tylan 40 Sulfa-G may be irritating to unprotected skin and eyes. When mixing and handling Tylan 40 Sulfa-G use protective clothing and impervious gloves. 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 in users or obtain a copy of the MSDS, call 1-800-428-4441.

For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.

Mixing and Feeding Directions: Thoroughly mix 2.5 pounds Tylan 40 Sulfa-G in one ton of Type C Feed to provide 100 grams of tylosin and 100 grams of sulfamethazine per ton.

NOT FOR HUMAN USE.

WARNING: Feeds containing Tylan 40 Sulfa-G must be withdrawn 15 days before swine are slaughtered.

Store at or below 25° C (77° F). Excursions permitted to 37° C (99° F). Avoid Moisture.

Not to be used after the date printed on bag.

Principal Display Panel - Tylan 40 Sulfa-G Bag Label

Elanco™

AF0904

Tylan™ 40 Sulfa-G™

Net Weight 50 lbs
(22.68 kg)

INGREDIENTS AND APPEARANCE

TYLAN 40 SULFA-G 
tylosin phosphate and sulfamethazine granule

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 58198-0904
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tylosin phosphate (UNII: NR75X12AFF) (tylosin - UNII:YEF4JXN031)	tylosin phosphate	88 g  in 1 kg
sulfamethazine (UNII: 48U51W007F) (sulfamethazine - UNII:48U51W007F)	sulfamethazine	88 g  in 1 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: 58198-0904-1	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA041275	10/18/2010

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