FDA.reportPublic FDA data

Mecadox

Manufacturer
Phibro Animal Health
Effective date
2023-11-02
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:42:25

Label at a glance#

ProductMecadox
Active ingredientCARBADOX
Label structure9 sections

Storage and handling

Store At Or Below 25 o C (77 o F), Excursions Permitted Up To 40 o C (104 o F)

Label contents#

Full prescribing information#

Active Drug Ingredient:

DESCRIPTION SECTION

Carbadox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2% (10 g/lb)

Indications for Use:

INDICATIONS & USAGE SECTION

Control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency in swine.

WARNING:

WARNINGS SECTION

For use in the manufacture of complete swine feeds and/or swine protein supplement feeds only.

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health 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.

Complete Swine Feed

DOSAGE & ADMINISTRATION SECTION

Mixing and Use Directions

Indications for Use

Amount of Drug

lb of Mecadox® 10 per ton of Complete Feed

Increased rate of weight gain and improved feed efficiency

0.0011-0.00275%

(10-25 g/ton)

1.0-2.5 lb

Control of swine dysentery (vibrionic dysentery, bloody scours or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); increased rate of weight gain and improved feed efficiency.

0.0055%

(50 g/ton)

5.0 lb

Protein Supplement

Mixing and Use Directions

Amount of Supplement per Ton of Complete Feed (lb)

lb of Mecadox® 10 per Ton of Protein Supplement

Desired Level of Mecadox® in Complete Feed

0.0055%

(50 g/ton)

0.00275%

(25 g/ton)

0.0011%

(10 g/ton)

1000

667

500

250

100

75

50

40

20

10

15

20

40

100

133

200

250

500

5

7

10

20

50

67

100

125

250

2

3

4

8

20

27

40

50

100

Warning:

WARNINGS SECTION

Do not feed to swine within 42 days before slaughter.

Caution: Not for use in pregnant swine or swine intended for breeding purposes.

Do not mix in feeds containing bentonite.

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

Storage and Handling

STORAGE AND HANDLING SECTION

Store At Or Below 25oC (77oF), Excursions Permitted Up To 40oC (104oF)

SPL UNCLASSIFIED SECTION

See Back PANEL for Further Use Directions

Mecadox® is a Phibro Animal Health Corporation registered trademark for Carbadox

Phibro Animal Health Corporation, Teaneck, NJ 07666.

Net Weight 40 lb (18.2 kg)

7913000

101-9383-01

Approved by FDA under NADA # 041-061

Mecadox 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mecadox 10Mecadox 10 LabelMecadox 10 Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66104-0006-0Mecadox22.6 kg in 1 BAGPOWDER22.69
66104-0006-4Mecadox18.2 kg in 1 BAGPOWDER18.29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66104-0006MECADOX (CARBADOX) POWDER [PHIBRO ANIMAL HEALTH]92 package rows20231103_df49e55f-c531-4ac8-8dc2-58dbb3291cdf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBADOXACTIVE INGREDIENTM2X04R2E2Y5
CARBADOXACTIVE MOIETYM2X04R2E2Y5
CALCIUM PROPIONATEINACTIVE INGREDIENT8AI80040KW5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP5
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD5

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66104-000666104-0006-4, 66104-0006-0

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
NameUNIIKind
CARBADOXM2X04R2E2YACTIB
MINERAL OILT5L8T28FGPIACT
CALCIUM PROPIONATE8AI80040KWIACT
SOYBEANL7HT8F1ZODIACT

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 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODEMULSION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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