Animal NDC 66104-2400-5 Rumatel 88

Morantel Tartrate

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-2400-5
Proprietary Name Rumatel 88 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Morantel Tartrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Phibro Animal Health
Product Type Otc Type A Medicated Article Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Morantel Tartrate
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • SODIUM ALUMINOSILICATE (058TS43PSM)
  • CALCIUM CARBONATE (H0G9379FGK)
  • SOYBEAN (L7HT8F1ZOD)
  • MINERAL OIL (T5L8T28FGP)
  • SODIUM ALUMINOSILICATE (058TS43PSM)
  • CALCIUM CARBONATE (H0G9379FGK)
  • SOYBEAN (L7HT8F1ZOD)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA092444 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Rumatel 88 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



For cattle and goats

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


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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.