Component E-C With Tylan

Manufacturer
Elanco US Inc.
Effective date
2025-11-21
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:45:19

Label at a glance#

ProductComponent E-C With Tylan
Active ingredientprogesterone, estradiol benzoate, tylosin tartrate
Label structure12 sections

Dosage and administration

Administer 1 implant - the entire contents of one cartridge cell (5 pellets) - subcutaneously in the back of the middle third of the ear. Study and carefully follow at all times the "IMPLANTING INSTRUCTIONS" presented below, avoiding short cuts. Skin infection can be avoided by properly preparing implant site and implanter. During fly season use fly repellent on implant site. One designated team member should alwa...

Storage and handling

Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT refrigerate – avoid excessive heat and humidity. Discard open foil pouches. Approved by FDA under NADA # 110-315 Manufactured by a non-sterilizing process. Component E-C with Tylan (progesterone and estradiol benzoate and tylosin tartrate implants) is covered by U.S. Patent No. 5,874,098 Component, Tylan, Elanco and the diagonal bar logo are tra...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Elanco™

Component™

E-C with Tylan™

(progesterone and estradiol benzoate and tylosin tartrate implant)

BEEF CALVES 45 DAYS OF AGE AND OLDER

AND WEIGHING UP TO 400 LBS

Each implant consists of 100 mg progesterone USP and 10 mg estradiol benzoate and 29 mg tylosin tartrate

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

IMPLANTS FOR BEEF CALVES 45 DAYS OF AGE AND OLDER AND WEIGHING UP TO 400 LBS

Use with a Component Implanter

DESCRIPTION:

DESCRIPTION SECTION

Each cartridge belt holds 20 doses of Component E-C with Tylan (progesterone and estradiol benzoate and tylosin tartrate implant) Implants. Each dose of 5 pellets consists of 4 pellets containing a total of 100 mg progesterone USP and 10 mg estradiol benzoate 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 beef calves 45 days of age and older and weighing up to 400 lbs.

This implant is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant as safety and effectiveness has not been evaluated.

Do not use in calves less than 45 days of age or veal calves because effectiveness and safety have not been evaluated.

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Administer 1 implant - the entire contents of one cartridge cell (5 pellets) - subcutaneously in the back of the middle third of the ear. Study and carefully follow at all times the "IMPLANTING INSTRUCTIONS" presented below, avoiding short cuts. Skin infection can be avoided by properly preparing implant site and implanter. During fly season use fly repellent on implant site. One designated team member should always do the implanting. Cleanliness of hands and instruments is important at all times.

Withdrawal Periods and Residue Warnings

No withdrawal period is required when used according to labeling.

Do not use in beef calves less than 45 days of age, dairy calves, and veal calves. Do not use in bull calves intended for reproduction. 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 in 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 use in humans. Keep out of reach of children.

Restricted Drug (California) – Use Only as Directed

ANIMAL SAFETY WARNINGS:

SPL UNCLASSIFIED SECTION

Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered Component E-C with Tylan Implants.

WARNINGS:

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.

IMPLANTING INSTRUCTIONS:

INSTRUCTIONS FOR USE SECTION

Loading the Implanter

SPL UNCLASSIFIED SECTION

Load the implanter following the instructions supplied with each implanter.

Figure
Figure

Restrain the Animal

SPL UNCLASSIFIED SECTION

Speed of implantation as well as safety of handlers is best achieved by restraining animal in a squeeze chute using head restraint.

Figure
Figure

Prepare the Implant Site

SPL UNCLASSIFIED SECTION

Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton or brush 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

SPL UNCLASSIFIED SECTION

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 and 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

After inserting the needle fully in the correct implant 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 a single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may lead to undesirable side effects such as bulling, rectal and vaginal prolapse, etc., as noted in the WARNINGS.

STORAGE CONDITIONS:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT refrigerate – avoid excessive heat and humidity. Discard open foil pouches.

Approved by FDA under NADA # 110-315

Manufactured by a non-sterilizing process.

Component E-C with Tylan (progesterone and estradiol benzoate and tylosin tartrate implants) 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 United Kingdom

Revised: June 2023

PA104028X            AH0507

Principal Display Panel - Component E-C With Tylan Cartridge Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™

™

E-C with Tylan™

(progesterone and estradiol benzoate and tylosin tartrate implants)

BEEF CALVES 45 DAYS OF AGE AND OLDER

AND WEIGHING UP TO 400 LBS

Cartridge Label
Cartridge Label

Principal Display Panel - Component E-C With Tylan Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™

™

E-C with Tylan™

(progesterone and estradiol benzoate and tylosin tartrate implant)

BEEF CALVES 45 DAYS OF AGE AND OLDER

AND WEIGHING UP TO 400 LBS

Each implant consists of 100 mg progesterone USP
and 10 mg estradiol benzoate and 29 mg tylosin tartrate

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

IMPLANTS FOR BEEF CALVES 45 DAYS OF AGE AND OLDER AND WEIGHING UP TO 400 LBS

Figure 3
Figure 3

Principal Display Panel - Component E-C With Tylan Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™

™

E-C with Tylan™

(progesterone and estradiol benzoate and tylosin tartrate implants)

BEEF CALVES 45 DAYS OF AGE AND OLDER

AND WEIGHING UP TO 400 LBS

Carton Label
Carton Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128304028com06-0004-05.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
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001f367b-fa14-49a0-865b-b395f2553601Product name220190611
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
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d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0507-2Component E-C With Tylan1 in 1 POUCHIMPLANT111
58198-0507-2Component E-C With Tylan5 in 1 CARTONIMPLANT511

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
58198-050758198-0507-2

Ingredients#

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

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

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROGESTERONEPROGESTERONEREMEDYREPACK INC.947ebb7c-492b-4b83-aa1c-81e282df64212026-08-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.404e0b45-339b-4304-8e33-5f4ffe8f8e252026-08-24Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ENDOMETRINPROGESTERONEFerring Pharmaceuticals Inc.2ba50fa9-b349-40cb-9a4b-1af8faa4ec092026-07-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEREMEDYREPACK INC.f7615864-be6e-47b4-bf35-145a361d7cc62026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PrometriumPROGESTERONEAcertis Pharmaceuticals, LLC1cf237ff-c4f8-4faa-a7aa-77599c8568892026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONERedpharm Drug5743b2e4-093f-c59a-e063-6394a90aae2b2026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENorthStar Rx LLCf392c6d9-1420-4735-aa01-f434da9b31b32026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEA-S Medication Solutionsbc62ae6d-b609-432d-863f-a8ecd223d69a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEGolden State Medical Supply, Inc.312db3af-9dd2-d5e4-e063-6394a90af9992026-06-18Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE42c84fec-e5eb-78f7-e063-6294a90a4c0e2026-06-16Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack1ba10f9d-6e91-4954-ac91-23adcf8805b02026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack74a7619a-8f74-4889-96f6-5bae478543e82026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEBionpharma Inc.41b3c3a7-5fb8-4451-a96c-2bd02613c0212026-05-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONESun Pharmaceutical Industries, Inc.fcdde0d0-4329-4725-a76b-684f9d97fe952026-05-19Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE1637ac18-3a37-f3d5-e063-6394a90af1572026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEA-S Medication Solutions566584fc-c76a-4e42-a62e-109a2903b9392026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
Natural ProgesteronePROGESTERONEBioActive Nutritional, Inc.772629aa-af5e-4493-aaf2-3c75bfd7d8c22026-05-05WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Incd8bcc439-c21d-4eeb-9159-f51e0c60bd702026-04-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONE VAGINAL INSERTSPROGESTERONEGlenmark Pharmaceuticals Inc., USA41682665-e889-4e2a-9382-88f6bcc302372026-04-17Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBioActive Nutritional, Inc.cddb5afa-9825-418d-acf6-cffbb0fc39c32026-03-10WarningsName fallback
generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

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