Label: EXPERIOR 10- lubabegron granule
- NDC Code(s): 58198-1567-1
- Packager: Elanco US Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated January 31, 2024
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- Official Label (Printer Friendly)
- Experior™10TM
- Important:
- Active Drug Ingredient:
- Inert Ingredients:
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Indications for Use:
For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
Effectiveness has not been demonstrated when fed for less than 14 days.
Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.
Increased rate of weight gain, improved feed efficiency, and increased carcass leanness have not been demonstrated with this product.
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Mixing Directions (Dry Type B Medicated Feeds):
Thoroughly mix Experior 10 Type A medicated article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B medicated feed (maximum 720 g/ton). The following table gives examples of how some Type B medicated feed concentrations can be prepared:
a Experior 10 contains 4.54 grams of lubabegron per pound b Based on 90% Dry Matter Basis Pounds of Experior 10 Type Aa
To Add Per Ton To Make
a Type B Medicated FeedResulting lubabegron Concentration in
Type B Medicated Feedbgrams/ton
9.9
45
77.1
350
158.6
720
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Mixing Directions (Liquid Type B Medicated Feeds):
Thoroughly mix Experior 10 Type A medicated article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (15.5 to 185 g/ton). If mixing less than 5 pounds of Type A medicated article per ton to make a Type B liquid medicated feed, you must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 10 Type A medicated article in a convenient quantity of feed ingredients or diluents, and then mix the pre-blend into the remaining feed ingredients or diluents to make a Type B liquid medicated feed.
Formulate medicated feed to a pH of 4 to 9 and dry matter content of 60% to 75%. Liquid Type B Medicated Feeds containing Experior stored in recirculation tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving no less than 1% of the tank contents per minute from the bottom to the top of the tank. 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 turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:
a Experior 10 contains 4.54 g lubabegron per pound Pounds of Experior 10 Type Aa
To Add Per Ton to Make a
Liquid Type B Medicated FeedResulting lubabegron Concentration in
Liquid Type B Medicated Feedgrams/ton
3.4
15.5
22.0
100
40.7
185
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Mixing Directions (Dry Type C Medicated Complete Feeds):
Thoroughly mix Experior 10 Type A medicated article in a ton of complete cattle feed according to the table below to obtain the proper concentration in the Type C medicated feed. You must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 10 Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend to the remaining feed ingredients to make a complete feed.
a Experior 10 contains 4.54 grams of lubabegron per pound b Based on 90% Dry Matter Basis c Rounded value Pounds of Experior 10 Type Aa
To Add Per Ton To Make a Type C Medicated FeedResulting lubabegron Concentration (g/ton)
in Type C Medicated Feedb0.28c
1.25
0.55
2.50
1.00
4.54
- Feeding Directions:
- Caution:
- Warnings:
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User Safety Warning:
The active ingredient in Experior 10, lubabegron, is a beta-adrenergic agonist/antagonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for human use. Keep out of reach of children. When mixing and handling Experior 10, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water; if wearing contact lenses, rinse eyes first, then remove contact lenses and continue to rinse for 5-20 minutes. If irritation persists, seek medical attention. The safety data sheet contains more detailed occupational safety information. To report adverse drug events, access medical information, or obtain additional product information, call Elanco US Inc. at 1-800-428-4441. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
Lot No:
Expiry Date:
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Storage Information:
Store at or below 25°C (77°F). Excursions permitted to 30°C (86°F).
Not to be used after the date printed on the bag.
Restricted Drug (California) – Use Only as Directed
Approved by FDA under NADA #141-508
Manufactured For:
Elanco US Inc.
2500 Innovation Way
Greenfield, IN 46140, U.S.A.
Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2021 Elanco or its affiliates
Net Weight 10 kg
(22.04 lb)TAKE TIME
OBSERVE LABEL
DIRECTIONSYL103063X
- Principal Display Panel – Experior 10kg Bag Label
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INGREDIENTS AND APPEARANCE
EXPERIOR 10
lubabegron granuleProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-1567 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lubabegron (UNII: 8501207BZX) (Lubabegron - UNII:8501207BZX) Lubabegron 10 g in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-1567-1 10 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141508 11/06/2018 Labeler - Elanco US Inc. (966985624)