Rumatel 88

Manufacturer
Phibro Animal Health
Effective date
2019-06-27
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:40:27

Label at a glance#

ProductRumatel 88
Active ingredientMORANTEL TARTRATE
Label structure8 sections

Dosage and administration

The following are examples in the approved range (0.44–4.4 g/lb) lb of feed per 100 lb of body weight lb of premix lb of nonmedicated feed Resulting concentration (g/lb) 1.0 10 1990 0.44 0.4 25 1975 1.10 0.2 50 1950 2.20 0.1 100 1900 4.40 Directions for Use of Medicated Ration Use a single therapeutic treatment. Medicated feed is to be fed at the rate of 0.44 grams of morantel tartrate per 100 lb of body weight. T...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For cattle and goats

Active Drug Ingredient:

DESCRIPTION SECTION

Morantel tartrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19.4% (88 g/lb)

Indications for Use:

INDICATIONS & USAGE SECTION

Cattle: For the removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum). 

Goats: For the removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylusaxei.

Warnings:Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated...

WARNINGS AND PRECAUTIONS SECTION

For use in the manufacture of medicated beef, dairy, and goat feeds.

CAUTION: 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.

Mixing and Use Directions

DOSAGE & ADMINISTRATION SECTION

The following are examples in the approved range (0.44–4.4 g/lb)

lb of feed per 100 lb of body weight

lb of premix

lb of nonmedicated feed

Resulting concentration (g/lb)

1.0

10

1990

0.44

0.4

25

1975

1.10

0.2

50

1950

2.20

0.1

100

1900

4.40

Directions for Use of Medicated Ration

Use a single therapeutic treatment. Medicated feed is to be fed at the rate of 0.44 grams of morantel tartrate per 100 lb of body weight. The medicated feed mix should be consumed within 6 hours. May be fed as the sole ration or mixed with 1–2 parts of complete feed or as a top dress. When used as a top dress the medication as well as the underlying feed should be evenly distributed. Animals should be grouped by size for optimum efficacy. Fresh water should be available at all times. When all medicated feed is consumed resume normal feeding. Conditions of constant worm exposure may require retreatment within 2–4 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Do not under dose. Ensure each animal receives a complete dose based on a current body weight. Under dosing may result in ineffective treatment, and encourage the development of parasite resistance.

WARNINGS:

WARNINGS SECTION

Do not treat cattle within 14 days of slaughter.

Do not treat goats within 30 days of slaughter. No milk

discard required following use in dairy cattle or goats.

CAUTION: Consult veterinarian before using in severely debilitated animals. Do not mix in feeds containing bentonite.

Restricted Drug (California) – USE AS DIRECTED

Store At or Below 25°C(77°F), Excursions Permitted Up to 40°C (104°F)

Not For Human Use

SPL UNCLASSIFIED SECTION

SEE BACK PANEL FOR FURTHER USE DIRECTIONS

Net Weight: 25 lb (11.3 kg)

Approved by FDA under NADA #092-444

7970000

101-8318-06B

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rumatel 88 - 6A
Rumatel 88 - 6A
Rumatel 88 - 6B
Rumatel 88 - 6B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66104-2400-5Rumatel 8811.3 kg in 1 BAGPOWDER11.38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66104-2400RUMATEL 88 (MORANTEL TARTRATE) POWDER [PHIBRO ANIMAL HEALTH]81 package rows20190628_118513d8-c2c4-4fb3-b85a-a8ca5d7a9c02.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MORANTEL TARTRATEACTIVE INGREDIENT5WF7E9QC3F4
MORANTELACTIVE MOIETY7NJ031HAX54
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP4
SODIUM ALUMINIUM SILICATEINACTIVE INGREDIENT058TS43PSM4
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD4

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
66104-240066104-2400-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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 · 49 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 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 OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 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 OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM ALUMINIUM SILICATESODIUM ALUMINOSILICATE058TS43PSMTABLET / ORAL94 mgExact identifier — unii candidate
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODEMULSION / TOPICAL3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact 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 OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
SOYBEANSOYBEANL7HT8F1ZODCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
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
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM ALUMINIUM SILICATESODIUM ALUMINOSILICATE058TS43PSMTABLET, EXTENDED RELEASE / ORAL94 mgExact identifier — unii candidate
2 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %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 OILT5L8T28FGPCREAM / TOPICAL2772 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.