Paylean 9
- Manufacturer
- Elanco US Inc.
- Effective date
- 2025-12-16
- Label type
- VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 02:45:43
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Elanco™
AF0602
Paylean™9
(ractopamine hydrochloride
Type A medicated article)
For Use in Finishing Swine Feeds Only
For further manufacturing only.
Net Weight 10 kg
(22.046 lbs)
SPL UNCLASSIFIED SECTION
Active Drug Ingredient: ractopamine hydrochloride - 9 g per lb (20 g per kg)
Important: Must be thoroughly mixed into feeds before use. Follow label directions.
INDICATIONS & USAGE SECTION
Indications for Use: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing at least 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter.
Not for use in swine intended for breeding.
Appropriate Concentration of Ractopamine Hydrochloride |
4.5 to 9.0 g/ton* |
(5 to 10 ppm) |
* No increased benefit has been shown when ractopamine hydrochloride concentrations in the diet are greater than 4.5 g/ton (5 ppm). |
Inert Ingredients: Ground corncobs.
| NC = No Change, ↑ = increased, ↓ = decreased, | ||||
| a Improvement was observed only in pigs weighing less than 250 lbs. | ||||
Last 45 lbs of Body Weight Gain | Last 90 lbs of Body Weight Gain | |||
Variable | 4.5 g/ton ractopamine HCl | 9.0 g/ton ractopamine HCl | 4.5 g/ton ractopamine HCl | 9.0 g/ton ractopamine HCl |
Carcass Fat | ↓a | ↓a | ↓ | ↓ |
10th Rib Backfat (3/4 location) | NC | NC | NC | ↓ |
Last Rib Backfat (midline) | NC | NC | NC | NC |
Loin Eye Area (10th Rib) | ↑a | ↑ | ↑ | ↑ |
Rate of Lean Gain | ↑ | ↑ | ↑ | ↑ |
Efficiency of Lean Gain | ↑ | ↑ | ↑ | ↑ |
Dressing Percentage | NC | ↑ | ↑ | ↑ |
DOSAGE & ADMINISTRATION SECTION
Mixing Directions: Thoroughly mix Paylean 9 Type A Medicated Article into one 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:
Pounds of Paylean 9 To Add Per Ton | Resulting Ractopamine HCl Concentration in Type B Medicated Feed | |
grams/ton | grams/pound | |
100 | 900 | 0.45 |
200 | 1,800 | 0.90 |
300 | 2,700 | 1.35 |
400 | 3,600 | 1.80 |
Thoroughly mix Paylean 9 Type A Medicated Article into one ton of complete swine 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 a ton of complete feed.
Pounds of Paylean 9 To Add | Resulting Ractopamine HCl Concentration |
0.5 | 4.5 grams/ton (5 ppm) |
1.0 | 9 grams/ton (10 ppm) |
Feeding Directions: Feed as the sole ration to finishing swine weighing at least 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter.
Warnings
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 Paylean, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Paylean Type A medicated article poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Paylean, 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: Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride.
Additional Recommendations: To help mitigate the signs identified in the Animal Safety Warnings section, see the Pork Quality Assurance (PQA Plus) and Transport Quality Assurance (TQA) recommendations for best practices in swine care during handling, transport, and marketing.
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?: For technical assistance or to report side effects, 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/reportamimalae.
Restricted Drug (California) - Use Only as Directed
Approved by FDA under NADA # 140-863
Manufactured for: Elanco US Inc. Indianapolis, IN 46221 Paylean™ 9
Paylean, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2025 Elanco or its affiliates
Revision Date: September 2025
TAKE TIME
OBSERVE LABEL
DIRECTIONS
YL243436X
LOT No.:
D.O.M.:
EXPIRY:
Principal Display Panel – 10 kg Bag Label
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58198-0602-8 | Paylean 9 | 10 kg in 1 BAG | GRANULE | 10 | 8 |
Products#
Every source-derived product name is available through these pages.
- Paylean 9
- ractopamine hydrochloride
- ractopamine
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58198-0602 | 58198-0602-8 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ractopamine hydrochloride | 309G9J93TP | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2025-11-21 | monthly-update | 2026-06-03 17:37:46 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
