Terramycin 100 MR

Manufacturer: Phibro Animal Health
Effective date: 2021-12-07
Label type: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 02:41:10

Label at a glance#

ProductTerramycin 100 MR

Active ingredientOXYTETRACYCLINE HYDROCHLORIDE

Label structure6 sections

Dosage and administration

FOR TYPE A MEDICATED ARTICLE QUANTITIES LESS THAN ONE POUND. MIX THE PROPER AMOUNT OF TYPE A MEDICATED ARTICLE WITH AT LEAST TEN POUNDS OF FEED INGREDIENTS TO MAKE A PREBLEND. ADD THE PREBLEND TO THE REMAINING FEED INGREDIENTS AND MIX THOROUGHLY. INDICATIONS FOR USE Use Level of Terramycin LB OF Terramycin 100MR/TON CALVES - MILK REPLACERS Treatment of bacterial enteritis caused by Escherichia coli susceptible to ...

Label contents#

Full prescribing information#

Active Drug Ingredient:

DESCRIPTION SECTION

Oxytetracycline (from Oxytetracycline Dihydrate Base) Equivalent to

Oxytetracycline Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . .100 grams per pound.

Inert ingredients:

SPL UNCLASSIFIED SECTION

Dextrose monohydrate.

CAUTION: CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

WARNINGS AND PRECAUTIONS SECTION

CAUTION: For use in manufacturing medicated animal feeds only. For use in dry milk replacers only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

MIXING AND USE DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

INDICATIONS FOR USE	Use Level of Terramycin	LB OF Terramycin 100MR/TON
CALVES - MILK REPLACERS
Treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline	10 mg/lb body weight daily Feed continuously for 7-14 days	20¹
¹Calf weighing 100 lbs. consuming 1 lb. of dry milk replacer mixed with one gallon water.
HONEY BEES
Control of American Foulbrood caused by Paenibacillus larvae, and European Foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline	200 mg/oz (Dusting) 200 mg/5 lb (Syrup) 800 mg/patty (Extender Patty)	See Mixing, Preparation, and Feeding Directions below

Mixing and Use Directions for Honey Bees

To manufacture a Type C medicated feed containing 200 mg of oxytetracycline hydrochloride activity per oz (dusting Type C Medicated feed) mix 7 lb of Terramycin 100MR with 211 lb of powdered sugar (for a total of 218 lb). The resulting Type C medicated is fed as-is for dusting or may be used to prepare syrup and extender patty feeds.

Feeding Directions for Dusting:

Dusting: Apply 1 oz (200 mg oxytetracycline) of dusting Type C medicated feed per colony every 4 to 5 days for a total of 3 applications. Apply the dust on the outer parts or ends of the frames.

Caution: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.

Preparation and Feeding Directions for Syrup:

Preparation: First dissolve 1 oz (200 mg oxytetracycline) of the dusting Type C medicated feed in a small quantity of water, then mix into 5 lb of 1:1 sugar syrup (equal parts sugar and water. w/w).

Feeding: Feed 5 lb of syrup (200 mg oxytetracycline) per colony every 4 to 5 days for a total of 3 applications. Bulk feed the syrup using feeder pails, or division board feeders, or by filling the combs. Prepare fresh syrup for each application.

Preparation and Feeding Directions for Extender Patty:

Preparation: Make one patty by mixing 4 oz (800 mg oxytetracycline) of the dusting Type C medicated with 5.8 oz. (165 g) of vegetable shortening and 11.6 oz (330 g) of sugar.

Feeding: Place one patty per colony on the top bars of the brood nest frames in a single application.

WARNING:

WARNINGS SECTION

►Withdrawal Periods and Residue Warnings: Remove at least 6 weeks prior to main honey flow. Type C medicated feeds should be fed in the spring or fall and consumed by the bees before main honey begins to avoid contamination of production honey. Honey stored during medication periods in combs for surplus honey should be removed following final medication of the bee colony and must not be used for human food.

Warning: Do not use in a manner contrary to state apiary laws and regulations. Each state has specific regulations relative to disease control and medications. Contact the appropriate official or state departments of agriculture for specific inter- and intrastate laws and regulations.

NOT FOR HUMAN USE.

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED.

SPL UNCLASSIFIED SECTION

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,

USE DIRECTIONS AND WARNINGS.

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health Corporation for Oxytetracycline

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates.

Phibro Animal Health Corporation, Teaneck, NJ 07666

Approved by FDA under NADA #095-143

7940000

101-9079-07

Net Weight 50 lb (22.7 kg)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66104-7940-0	Terramycin 100 MR	22.7 kg in 1 BAG	POWDER	22.7		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66104-7940	TERRAMYCIN 100 MR (OXYTETRACYCLINE) POWDER [PHIBRO ANIMAL HEALTH]	8	1 package rows	20211208_eb3b6a04-da2a-43c0-93b6-bcc1d2e252c2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OXYTETRACYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	4U7K4N52ZM	4
OXYTETRACYCLINE ANHYDROUS	ACTIVE MOIETY	SLF0D9077S	4
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	4

Products#

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

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

Terramycin 100 MR
oxytetracycline
OXYTETRACYCLINE HYDROCHLORIDE
OXYTETRACYCLINE ANHYDROUS
DEXTROSE, UNSPECIFIED FORM
SILICON DIOXIDE
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66104-7940	66104-7940-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OXYTETRACYCLINE HYDROCHLORIDE	4U7K4N52ZM	ACTIB
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 148 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	CONCENTRATE / ORAL	400 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION, SOLUTION / INTRAVENOUS	51.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, EXTENDED RELEASE / ORAL	103.95 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRASPINAL	75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / ORAL	183.66 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii candidate 78 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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