Optaflexx 45

Manufacturer
Elanco US Inc.
Effective date
2026-01-16
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:45:48

Label at a glance#

ProductOptaflexx 45
Active ingredientractopamine hydrochloride
Label structure6 sections

Storage and handling

Storage and Handling: Store at less than or equal to 25°C (77°F). Excursions to 40°C (104°F) are acceptable. Avoid excessive moisture. Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date. QUESTIONS/COMMENTS? To report side effects, access medical information, or obtain additional product information, contact Elanco US Inc. at 1-800-428-4441. For additional information about ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Elanco™

AF0630

Optaflexx™45

(ractopamine hydrochloride Type A medicated article)

For use in Feeds for Growing Beef Steers and Heifers Fed in Confinement for Slaughter Only

Net Weight 25 lb
(11.34 kg)

For further manufacturing only.

SPL UNCLASSIFIED SECTION

Active Drug Ingredient: Ractopamine Hydrochloride - 45.4 g per lb (100 g per kg)

Inert Ingredients: Ground corn cobs.

Important: Must be thoroughly mixed into feeds before use. Follow label directions.

INDICATIONS & USAGE SECTION

Indications for Use: Complete Type C Medicated Feeds: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Not for use in cattle intended for breeding.

Type C Top-Dress Medicated Feeds: For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed. Not for use in cattle intended for breeding. Note: Increased carcass leanness is not an approved indication for use with Top-Dress Feeding.

Approved Concentrations of Ractopamine Hydrochloride in Complete Type C Medicated Feeds

a Based on 90% Dry Matter Basis

Indications for Use

Concentration of Ractopamine
Hydrochloride in Type C
Medicated Feed a

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

Carcass Measurements

Effect of Ractopamine Hydrochloride a

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

↑

↑

Approved Concentrations of Ractopamine Hydrochloride in Type C Top-Dress Medicated Feeds

a Based on 90% Dry Matter Basis

Indications for Use

Concentration of Ractopamine HCl in
Type C Top-Dress Medicated Feed a

Ractopamine
HCl (mg/hd/d)

Increased Rate of Weight Gain and Improved Feed Efficiency

100 to 800 g/ton in a minimum of 1 lb of Type C Top-Dress Medicated Feed

70-400

Mixing Directions for Complete Type C Medicated Feeds: Thoroughly mix Optaflexx 45 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 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 HCl Concentration in
Type B Medicated Feed b

grams/ton

grams/pound

32.8

500

0.25

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 HCl 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 for Type B Liquid Medicated Feeds: Thoroughly mix Optaflexx 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 2,300 g/ton).

Maintain supplement pH at 4.5 to 7.5. For stored Type B Liquid 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 Liquid 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
Type B Liquid Medicated Feed

Resulting Ractopamine HCl Concentration
in Type B Liquid Medicated Feed

grams/ton

grams/pound

36.1

1,640

0.82

44.1

2,000

1

50.7

2,300

1.15

Mixing Directions for Type C Top-Dress Medicated Feeds: Thoroughly mix Optaflexx 45 Type A Medicated Article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type C Top-Dress Medicated Feed (100 to 800 g/ton).

The following table gives examples of how some Type C Top-Dress 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 Type C Top-Dress Medicated Feed

Resulting Ractopamine HCl
Concentration in Type C Top-Dress
Medicated Feed b

Top-Dress

grams/ton

grams/pound

mg/pound

2.2

100

0.05

50

4.41

200

0.1

100

6.61

300

0.15

150

8.81

400

0.2

200

17.62

800

0.4

400

Feeding Directions Complete Type C Medicated Feed: Feed as the sole ration during the last 28 to 42 days on feed.

Type C Top-Dress Medicated Feed: Feed a minimum of 1 lb per head per day of Type C top-dress medicated feed containing 100 to 800 g/ton of ractopamine hydrochloride to provide 70 to 400 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed.

Warnings

WARNINGS SECTION

Withdrawal Periods:

No withdrawal period is required when used according to labeling.

User Safety Warnings: Not for use in humans. Keep out of reach of children. The active ingredient in Optaflexx, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. The Optaflexx 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. To obtain a Safety Data Sheet(s), contact Elanco US Inc. at 1-800-428-4441.

Animal Safety Warnings: Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.

Additional Recommendations: See the Beef Quality Assurance (BQA) recommendations for best practices in cattle care and handling during Optaflexx feeding, transport, and marketing to help mitigate the behavioral signs stated in the Animal Safety Warnings section above.

STORAGE AND HANDLING SECTION

Storage and Handling: Store at less than or equal to 25°C (77°F). Excursions to 40°C (104°F) are acceptable. Avoid excessive moisture.

Expiration Date and Lot Number are printed on the bag.

Not to be used after the expiry date.

QUESTIONS/COMMENTS? To report side effects, access medical information, or obtain additional product information, contact Elanco US Inc. at 1-800-428-4441.

For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

Restricted Drug (California) - Use Only as Directed

Approved by FDA under NADA # 141-221

Take Time Observe Label Directions
Take Time Observe Label Directions

Optaflexx™ 45

Manufactured for:       Elanco US, Inc

                                       Indianapolis, IN 46221

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

© 2025 Elanco or its affiliates

Revision Date: NOV/2025

BG243489X
YL243489X

Lot
DOM
EXP

Principal Display Panel – 25 lb Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

AF0630

Optaflexx™45

(ractopamine hydrochloride Type A medicated article)

For use in Feeds For Growing Beef Steers and
Heifers Fed in Confinement for Slaughter Only

Net Weight 25 lb
(11.34 kg)

Optaflexx 45 (ractopamine hydrochloride Type A medicated article) label
Optaflexx 45 (ractopamine hydrochloride Type A medicated article) label
Optaflexx 45 (ractopamine hydrochloride Type A medicated article) label
Optaflexx 45 (ractopamine hydrochloride Type A medicated article) label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0630-9Optaflexx 4511.34 kg in 1 BAGPOWDER11.347

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-063058198-0630-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ractopamine hydrochloride309G9J93TPACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-11-21monthly-update2026-06-03 17:37:46

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.