Label: TYLOVET 40 TYPE A MEDICATED ARTICLE- tylosin phosphate powder
- NDC Code(s): 23243-2355-1
- Packager: Huvepharma, Inc.
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated April 11, 2023
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- SPL UNCLASSIFIED SECTION
- PRECAUTIONS
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INDICATIONS & USAGE
Equivalent to 40 g Tylosin per Pound
Swine:
For the 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 Tylovet 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 Tylovet Soluble (tylosin)
in drinking water.Beef Cattle:
For reduction of incidence of liver abscesses associated with Fusobacterium
necrophorum and Arcanobacterium pyogenes. - GENERAL PRECAUTIONS
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ADVERSE REACTIONS
To report suspected adverse drug events, for technical assistance or to obtain
a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc., at
1-877-994-4883 or www.huvepharma.us. For additional information about adverse
drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae.Net Weight: 50 lbs (22.68 kg)
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INDICATIONS & USAGE
Directions for Use Read All Directions Carefully
Before Mixing and FeedingTylovet® 40 Type A Medicated Article Net Weight: 50 lbs
Do Not Feed Undiluted. (22.68 kgs)
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 lb
Ingredients: Roughage products, pregelatanized starch and dipotassium phosphate.
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.Warning:Tylovet 40 may be irritating to unprotected skin and eyes. When mixing and handling
Tylovet 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 Safety Data Sheet (SDS) contains more detailed occupational
safety information. To report adverse effects, access medical information, or obtain additional
product information, call 1-877-994-4883.For reduction in severity of effects of atrophic rhinitis. Feed 100 g of tylosin per ton
(2.5 pounds Tylovet 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 Tylovet 40 per ton)
of complete feed for at least three weeks. Follow with 40 g tylosin per ton (1.0 pound
Tylovet 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 Tylovet 40) per ton of complete feed for 2 to 6 weeks immediately after
medicating with 250 mg tylosin (as Tylovet Soluble) per gallon in drinking water for 3 to 10
days.For the control of porcine proliferative enteropathies (PPE, ileitis). Feed 100 g tylosin
per ton (2.5 pound Tylovet 40 per ton) of complete feed for 21 days. Alternatively, feed 100 g
of tylosin per ton (2.5 pound Tylovet 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 Tylovet 40) per ton of complete feed for 2
to 6 weeks immediately after medicating with 250 mg tylosin (as Tylovet Soluble) per gallon in
drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylovet.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 pyogenesTylovet 40 per Ton
Of Type C FeedTylosin Per Ton of
Type C Feed0.2 to 0.25 lbs
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.8 to 10 g
Mixing Directions
for Liquid Type B
Cattle FeedsLIMITATIONS:
1. pH must be between 4.5 and 6.0.
2. 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.
3. 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.
4. Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture. - SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TYLOVET 40 TYPE A MEDICATED ARTICLE
tylosin phosphate powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:23243-2355 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TYLOSIN PHOSPHATE (UNII: NR75X12AFF) (TYLOSIN - UNII:YEF4JXN031) TYLOSIN 40 g in 0.45 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23243-2355-1 22.68 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200484 07/13/2018 Labeler - Huvepharma, Inc. (619153559) Registrant - Huvepharma EOOD (552671651)
