ACTOGAIN- ractopamine hydrochloride powder

Actogain by

Drug Labeling and Warnings

Actogain by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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For Use in Feeds For Cattle Fed in
Confinement for Slaughter Only

Type A Medicated Article

Do not Feed Undiluted

DESCRIPTION

Active Drug Ingredient: Ractopamine hydrochloride – 45.4 g per lb (100 g per kg)
Important: Must be thoroughly mixed into feeds before use. Follow label directions.
Indication: Complete Feed:	For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Top Dress Feed:	For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Note:	Carcass leanness effects are not an approved indication for use when feeding ractopamine by Top Dress Feeding methods.

Complete Feed

Indications	Appropriate Concentration of Ractopamine in Type C Medicated Feed*	Ractopamine (mg/hd/d)
* Based on 90% Dry Matter Basis
Increased Rate of Weight Gain, and Improved Feed Efficiency	8.2 to 24.6 g/ton (9 to 27 ppm)	70-430
Increased Rate of Weight Gain, Improved Feed Efficiency, and Increased Carcass Leanness	9.8 to 24.6 g/ton (11 to 27 ppm)	90-430

Carcass Measurements	Effect of Ractopamine*
	8.2 grams/ton (9 ppm)	16.4 grams/ton (18 ppm)	24.6 grams/ton (27 ppm)
NC= No Change, ↑= increased, ↓ = decreased
* The effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials. † Steers Only ‡ Reduction indicates an improvement in USDA Yield Grade.
Hot Carcass Weight, lbs	↑	↑	↑
Dressing Percentage, %	NC	↑†	↑†
Carcass Percent Fat, %	NC	↓	↓
12th Rib Fat Thickness, in.	NC	NC	NC
Average Rib Eye Area, sq. in.	↑	↑	↑
USDA Yield Grade	NC	NC	↓‡
Marbling Score	NC	NC	NC
Rate of Carcass Lean Gain per Day	NC	↑	↑
Efficiency of Carcass Lean Gain per Day	NC	↑	↑

Top Dress Feed

Indications	Appropriate Concentration of Ractopamine in Type C Medicated Feed*	Ractopamine (mg/hd/d)
* Based on 90% Dry Matter Basis
Increased Rate of Weight Gain and Improved Feed Efficiency	Appropriate Concentration of Ractopamine in a minimum of 1.0 lb Top Dressed Type C Medicated Feed* (maximum of 800 g/ton)	70-400

Inert Ingredients: Ground corncobs.

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Mixing Directions (Complete Feed): Thoroughly mix Actogain 45 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 (maximum 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

Pounds of Actogain 45* to Add per Ton To Make a Type B Medicated Feed	Resulting Ractopamine Concentration in Type B Medicated Feed†
	grams/ton	grams/pound
* Actogain 45 contains 45.4g ractopamine hydrochloride per pound † Based on 90% Dry Matter Basis
36.1	1,640	0.82
72.2	3,280	1.64
108.3	4,920	2.46

Thoroughly mix Actogain 45 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. Prepare an intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients then add to the remaining feed ingredients to make one ton of complete feed.

Pounds of Actogain 45* to Add per Ton To Make a Type C Medicated Feed	Resulting Ractopamine Concentration in Type C Medicated Feed†
* Actogain 45 contains 45.4g ractopamine hydrochloride per pound † Based on 90% Dry Matter Basis
0.18	8.2 grams/ton (9 ppm)
0.36	16.4 grams/ton (18 ppm)
0.54	24.6 grams/ton (27 ppm)

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Mixing Directions (Liquid Type B Feeds): Thoroughly mix Actogain 45 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 (maximum 2300 g/ton).

Maintain supplement pH to 4.5 to 7.5. For stored liquid Type B medicated feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use.

The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

Pounds of Actogain 45* to Add per Ton To Make a Liquid Type B Medicated Feed	Resulting Ractopamine Concentration in Liquid Type B Medicated Feed
	grams/ton	grams/pound
* Actogain 45 contains 45.4g ractopamine hydrochloride per pound
36.1	1,640	0.82
44.1	2,000	1.00
50.7	2,300	1.15

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Mixing Directions for preparing Type C Medicated Top Dress Feed: Thoroughly mix Actogain 45 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 C Medicated Feed (maximum 800 g/ton). The following table gives examples of how some Type C Medicated Top Dress Feed concentrations can be prepared:

Pounds of Actogain 45* to Add per Ton To Make a Type C Medicated Top Dress Feed	Resulting Ractopamine Concentration in Type C Medicated Top Dress Feed†
Top Dress	grams/ton	grams/pound	mg/pound
* Actogain 45 contains 45.4g ractopamine hydrochloride per pound † Based on 90% Dry Matter Basis
2.20	100	0.05	50
4.41	200	0.10	100
6.61	300	0.15	150
8.81	400	0.20	200
17.62	800	0.40	400

DOSAGE & ADMINISTRATION

Directions for Use (Complete Feed): Feed continuously to cattle fed in confinement for slaughter as the sole ration for the last 28 to 42 days on feed.

Directions for Use (Type C Medicated Top Dress Feed): Feed continuously to cattle fed in confinement for slaughter a Type C Medicated Feed containing up to a maximum of 800 g/ton ractopamine (see mixing direction table) to provide 70 to 400 mg per head per day for the last 28 to 42 days on feed. Type C Medicated Top Dress feed must be fed in a minimum of 1.0 lb per head per day to provide 70 to 400 mg per head per day.

PRECAUTIONS

CAUTION: Not for animals intended for breeding.

NOT FOR HUMAN USE

BOXED WARNING

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WARNING: The active ingredient in Actogain, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Actogain 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Actogain, 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 eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-888-963-8471.

STORAGE AND HANDLING

Store below 25ºC (77ºF), excursions permitted to 40ºC (104ºF). Avoid Moisture.

Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date.

Restricted Drug (California) – Use Only as Directed – ANADA # 200-548, Approved by FDA

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Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

ADVERSE REACTIONS

To report adverse effects, access medical information, or obtain additional product information, call 1-888-963-8471.

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Product No.: 1RAC402     3830000
8RAC402 Rev: 07/13        13742501

PRINCIPAL DISPLAY PANEL - 11.34 kg Bag

For Use in Feeds For Cattle Fed in
Confinement for Slaughter Only

Actogain™ 45
Ractopamine Hydrochloride

Net Weight 25 lb (11.34 kg)

INGREDIENTS AND APPEARANCE

ACTOGAIN 
ractopamine hydrochloride powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 54771-8728
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RACTOPAMINE HYDROCHLORIDE (UNII: 309G9J93TP) (RACTOPAMINE - UNII:57370OZ3P1)	RACTOPAMINE HYDROCHLORIDE	100 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-8728-1	11.34 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200548	07/18/2013

Labeler - Zoetis Inc. (828851555)