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Animal NDC 58198-0040-1 Tylan 40

Tylosin Phosphate

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-0040-1
Proprietary Name Tylan 40 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Tylosin Phosphate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Elanco Us Inc.
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
    Read All Directions CarefullyBefore Mixing and FeedingTylan™ 40 Type A Medicated ArticleDo 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 Ingredient(s)
  • Tylosin Phosphate
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • RICE BRAN (R60QEP13IC)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • RICE BRAN (R60QEP13IC)
  • CALCIUM CARBONATE (H0G9379FGK)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA012491 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Tylan 40 Images

Tylan 40 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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

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

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.


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.

BG102344X

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.


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 FeedsLIMITATIONS:
  • 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 (77°F). 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)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.