OPTAFLEXX 45- ractopamine hydrochloride powder 
Elanco US Inc.

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Elanco™

AF0630

Optaflexx™45

(ractopamine hydrochloride Type A medicated article)

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

Net Weight 25 lb
(11.34 kg)

Do Not Feed Undiluted

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

a Based on 90% Dry Matter Basis

Indications

Appropriate Concentration of Ractopamine in Type C Medicated Feed a

Ractopamine
(mg/hd/d)

Increased Rate of Weight Gain, and Improved Feed Efficiency

8.2 to 24.6 g/ton
(9 ppm 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 ppm to 27 ppm)

90-430

a 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.
NC = No Change, ↑ = Increased, ↓ = Decreased
b Steers Only
c Reduction indicates an improvement in USDA Yield Grade.

Carcass Measurements

Effect of Ractopaminea

8.2 grams/ton
(9 ppm)

16.4 grams/ton
(18 ppm)

24.6 grams/ton
(27 ppm)

Hot Carcass Weight, lbs

Dressing Percentage, %

NC

b

b

Carcass Percent Fat, %

NC

12th Rib Fat Thickness, in.

NC

NC

NC

Average Rib Eye Area, sq. in.

USDA Yield Grade

NC

NC

c

Marbling Score

NC

NC

NC

Rate of Carcass Lean Gain per Day

NC

Efficiency of Carcass Lean Gain per Day

NC

Top Dress Feed

a Based on 90% Dry Matter Basis

Indications

Appropriate Concentration of Ractopamine in Type C Medicated Feed a

Ractopamine
(mg/hd/d)

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 Feeda (maximum of 800 g/ton)

70-400

Inert Ingredients: Ground corn cobs.

Mixing Directions (Complete Feed):

Thoroughly mix Optaflexx 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:

a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis

Pounds of Optaflexx 45 a To Add Per Ton To Make a
Type B Medicated Feed

Resulting Ractopamine Concentration in Type B Medicated Feed b

grams/ton

grams/pound

36.1

1,640

0.82

72.2

3,280

1.64

108.3

4,920

2.46

Thoroughly mix Optaflexx 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.

a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis

Pounds of Optaflexx 45 a Per Ton To Make a Type C Medicated Feed

Resulting Ractopamine Concentration in Type C Medicated Feed b

0.18

8.2 grams/ton (9 ppm)

0.36

16.4 grams/ton (18 ppm)

0.54

24.6 grams/ton (27 ppm)

Mixing Directions (Liquid Type B Feeds):

Thoroughly mix Optaflexx 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 at 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:

a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound

Pounds of Optaflexx 45 a 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

36.1

1,640

0.82

44.1

2,000

1.00

50.7

2,300

1.15

Mixing Directions for Preparing Type C Medicated Top Dress Feed:

Thoroughly mix Optaflexx 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:

a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
b Based on 90% Dry Matter Basis

Pounds of Optaflexx 45 a To Add Per Ton To Make Type C Medicated Top Dress Feed

Resulting Ractopamine Concentration in Type C Top Dress Medicated Feed b

Top Dress

grams/ton

grams/pound

mg/pound

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

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/head/ 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/head/day.

CAUTION: Not for animals intended for breeding.

Warning

Withdrawal Period:

No withdrawal period is required when used according to labeling.

NOT FOR HUMAN USE

WARNING: The active ingredient in Optaflexx, 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 Optaflexx 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Optaflexx, 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 1-800-428-4441.

Store at Room Temperature. 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 -

Approved by FDA under NADA # 141-221

Optaflexx™ 45

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.

Optaflexx, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

BG230548X

Principal Display Panel – 25 lb Bag Label

Elanco™

AF0630

Optaflexx™45

(ractopamine hydrochloride Type A medicated article)

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

Net Weight 25 lb
(11.34 kg)

Principal Display Panel – 25 lb Bag Label
Principal Display Panel – 25 lb Bag Label
OPTAFLEXX 45 
ractopamine hydrochloride powder
Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-0630
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1) ractopamine hydrochloride45.4 g  in 0.45 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58198-0630-911.34 kg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14122106/03/2010
Labeler - Elanco US Inc. (966985624)
Establishment
NameAddressID/FEIBusiness Operations
Evonik Corporation130890994API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
TriRx Speke Limited228138655MANUFACTURE, PACK, LABEL

Revised: 7/2022
Document Id: f0a597aa-ce24-40cf-95c6-537694d77b2b
Set id: 48b0f54c-57ee-445b-9f53-817cfaba38ad
Version: 4
Effective Time: 20220711
 
Elanco US Inc.