RUMATEL 88- morantel tartrate powder

Rumatel 88 by

Drug Labeling and Warnings

Rumatel 88 by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For cattle and goats

Active Drug Ingredient:

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

Indications for Use:

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 may slow the development of parasite resistance.Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of fecal egg count reduction test or another appropriate method).A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.CAUTION:

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

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:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUMATEL 88 
morantel tartrate powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-2400
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MORANTEL TARTRATE (UNII: 5WF7E9QC3F) (MORANTEL - UNII:7NJ031HAX5)	MORANTEL TARTRATE	88 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM ALUMINOSILICATE (UNII: 058TS43PSM)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SOYBEAN (UNII: L7HT8F1ZOD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-2400-5	11.3 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA092444	03/25/2010

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)