Component TE-G With Tylan

Manufacturer
Elanco US Inc.
Effective date
2025-11-21
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:45:20

Label at a glance#

ProductComponent TE-G With Tylan
Active ingredienttrenbolone acetate, estradiol, tylosin tartrate
Label structure9 sections

Storage and handling

Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity. Use before the expiration date printed on foil pouch. Discard open foil pouches. Approved by FDA under ANADA # 200-221 Manufactured by a non-sterilizing process. Component TE-G with Tylan is covered by U.S. Patent No. 5,874,098 Component, Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2023 Elan...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Elanco™

Component™

TE-G with Tylan™

(trenbolone acetate and estradiol and tylosin tartrate implants)

FOR GROWING BEEF STEERS AND HEIFERS ON PASTURE (Stocker, Feeder, and Slaughter)

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

20 dose Cartridge Belt

Use with a Component Implanter

DESCRIPTION:

DESCRIPTION SECTION

Each cartridge belt holds 20 doses of Component TE-G with Tylan (trenbolone acetate and estradiol and tylosin tartrate implant) Implants. Each dose of 3 pellets consists of 2 pellets containing a total of 40 mg of trenbolone acetate and 8 mg estradiol plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial.

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

For increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter).

Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Safety and effectiveness following re-implantation have not been evaluated.

Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been established.

Do not use in animals intended for subsequent breeding, or in dairy cows.

WARNING:

WARNINGS SECTION

This product is intended for use in cattle at high risk of developing ear abscesses. Not recommended for use in cattle at low risk of developing ear abscesses (e.g., dry, clean cattle).

The benefit of using a cattle ear implant containing a tylosin tartrate pellet when animals receive a concomitant antimicrobial product has not been evaluated.

Withdrawal Periods and Residue Warnings
No withdrawal period is required when used according to labeling.
Do not use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.
Implant pellets subcutaneously in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.

USER SAFETY WARNINGS:

USER SAFETY WARNINGS SECTION

Not for human use. Keep out of reach of children.

Restricted Drug (California) - use only as directed.

IMPLANTING INSTRUCTIONS:

SPL UNCLASSIFIED SECTION

Loading the Implanter

Load the implanter following the instructions supplied with each implanter.

Figure
Figure

Restrain the Animal

Speed of implantation as well as safety of handlers is best achieved by restraining animal in a squeeze chute using head restraint. When implanting horned cattle, better control is obtained with additional use of nose tongs.

Figure
Figure

Prepare the Implant Site

Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton which has been soaked with topical germicidal solution. Follow manufacturer’s directions on germicide for correct strength and preparation of solution. Avoid getting disinfectant in animal’s eyes.

Where to Implant

The full contents of one cartridge cell should be implanted beneath the skin on the back side of the middle one-third of the ear as illustrated in the drawing. The implant must not be closer to the head than the edge of the auricular cartilage ring farthest from the head. The location for insertion of the needle is a point toward the tip of the ear at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear.

Figure
Figure

Insert the Needle

With one hand firmly grasp the ear. With the other hand insert needle point through the skin and ease forward on a lateral plane until the entire length of the needle is under the skin.

Figure
Figure

Implant the Pellets

After inserting the needle fully in the correct position, squeeze the trigger fully as the needle is withdrawn from the ear. This properly deposits the implant in the needle track. This procedure should prevent breakage or crushing of pellets if otherwise forced into contact with tough fibrous-tissue underlying the skin. The length and total contact area of the single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may interfere with rates of gain.

Storage Conditions

STORAGE AND HANDLING SECTION

Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity.
Use before the expiration date printed on foil pouch. Discard open foil pouches.

Approved by FDA under ANADA # 200-221

Manufactured by a non-sterilizing process.

Component TE-G with Tylan is covered by U.S. Patent No. 5,874,098

Component, Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2023 Elanco or its affiliates

Distributed by Elanco US Inc,
Greenfield, IN 46140, USA

Tylosin: Product of the United Kingdom

QUESTIONS/COMMENTS? For a copy of the Safety Data Sheet or to report side effects, contact Elanco US, Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

April 2023

PA104024X       AH0369

Principal Display Panel - Cartridge Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™

TE-G with Tylan™

™

(trenbolone acetate and estradiol and tylosin tartrate implants)

For Growing Beef Steers and Heifers on
Pasture (Stocker, Feeder, and Slaughter)

One 20-Dose
Cartridge Belt

Principal Display Panel - Cartridge Label
Principal Display Panel - Cartridge Label

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™

TE-G with Tylan™

™

(trenbolone acetate and estradiol and tylosin tartrate implants)

For Growing Beef Steers and Heifers on
Pasture (Stocker, Feeder, and Slaughter)

Principal Display Panel - Carton Label
Principal Display Panel - Carton Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ESTRADIOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128104024com0a-0003-06.jpg
Data codeCode 128304024com0a-0003-05.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0369-2Component TE-G With Tylan1 in 1 POUCHIMPLANT110
58198-0369-2Component TE-G With Tylan5 in 1 CARTONIMPLANT510

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-036958198-0369-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
trenbolone acetateRUD5Y4SV0SACTIB
estradiol4TI98Z838EACTIB
tylosin tartrate5P4625C51TACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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