Animal NDC 23243-2320-5 Prohibit Soluble Drench Powder
Levamisole Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 23243-2320-5 |
| Proprietary Name | Prohibit Soluble Drench Powder 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 | Levamisole Hydrochloride 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 | Huvepharma, Inc |
| Product Type | Otc Animal Drug |
| Usage Information |
|
| Active Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED 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 | ANADA200225 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. |
Prohibit Soluble Drench Powder Images
Prohibit Soluble Drench Powder 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.
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NDC 23243-2320-5
PROHIBIT®
(levamisole hydrochloride)
Soluble Drench Powder
Anthelmintic
Each packet contains 46.8 grams of levamisole hydrochloride activity.
NDC 23243-2320-6
PROHIBIT®
(levamisole hydrochloride)
Soluble Drench Powder
Anthelmintic
Veterinary Indications
CATTLE AND SHEEP DEWORMER FOR ORAL USE
Administer as a standard drench with standard drench syringe or administer as a concentrated
drench solution with an automatic drenching syringe.
INDICATIONS:
Prohibit (levamisole hydrochloride) is a broad-spectrum anthelmintic and is effective against
the following nematode infections in cattle and sheep:
SHEEP:
STOMACH WORMS: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta.
INTESTINAL WORMS: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger,
Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina.
LUNGWORMS: Dictyocaulus filaria.
CATTLE:
STOMACH WORMS: Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi.
INTESTINAL WORMS: Trichostrongylus longlspicularis, Cooperia oncophora, Cooperia punctata,
Nematodirus spathiger, Bunostomum phiebotomum, Oesophagostomum radiatum.
LUNGWORMS: Dictyocaulus viviparus.
CATTLE AND SHEEP DEWORMER
FOR ORAL USE
This bottle contains 544.5 grams of
levamisole hydrochloride activity.
INDICATIONS: PROHIBIT (levamisole hydrochloride) is a broad-spectrum anthelmintic and is
effective against the following nematode infections in cattle and sheep:
SHEEP:
STOMACH WORMS: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta.
INTESTINAL WORMS: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger,
Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina.
LUNGWORMS: Dictyocaulus filaria.
CATTLE:
STOMACH WORMS: Haemonchus placei, Trichostrongylus axei, Ostertagia ostertagi.
INTESTINAL WORMS: Trichostrongylus longlspicularis, Cooperia oncophora, Cooperia punctata,
Nematodirus spathiger, Bunostomum phiebotomum, Oesophagostomum radiatum.
LUNGWORMS: Dictyocaulus viviparus.
General Precautions
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) Use Only as Directed
Approved by FDA under ANADA # 200-225
NET WEIGHT: 1.8 oz (52 g)
HUVEPHARMA®
Manufactured for Huvepharma, Inc.
Peachtree City, GA 30269
®Registered Trademark of Huvepharma, Inc.
CAUTION: Muzzle foam may be observed. However, this reaction will
disappear within a few hours. If this condition persists, a veterinarian
should be consulted. Follow recommended dosage carefully. Consult
veterinarian before using in severely debilitated animals.
Consult your veterinarian for assistance in the diagnosis, treatment,
and control of parasitism.
Not For Use in Humans
Keep Out of Reach of Children
Restricted Drug (California) -
Use Only as Directed
Approved by FDA under ANADA # 200-225
Net Wt: 21.34 oz (1.3 lb.) (605 g)
CAUTION: Muzzle foam may be observed. However, this reaction will disappear within a few
hours. If this condition persists, a veterinarian should be consulted. Follow recommended
dosage carefully. Consult veterinarian before using in severely debilitated animals.
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
Dosage & Administration
DOSAGE AND ADMINISTRATION
CATTLE–STANDARD DRENCH SOLUTION: Place the contents of this packet in a 1 quart (32 fl. oz.) container, fill with water, swirl until dissolved. Administer as a single drench dose according to the following table: | SHEEP–STANDARD DRENCH SOLUTION: Place the contents of this packet in a 1 gallon (128 fl. oz.) container, fill with water, swirl until dissolved. Administer as a single drench dose according to the following table: | ||||
Weight | Drench dosage | Packet Will Treat | Weight | Drench Dosage | Packet Will Treat |
200 lb. | 1/2 fl. oz. | 64 head | 50 lb. | 1/2 fl. oz. | 256 head |
400 lb. | 1 fl. oz. | 32 head | 100 lb. | 1 fl. oz. | 128 head |
650 lb. | 1 1/2 fl. oz. | 21 head | 150 lb. | 1 1/2 fl. oz. | 84 head |
800 lb. | 2 fl. oz. | 16 head | 200 lb. | 2 fl. oz. | 64 head |
CONCENTRATED DRENCH SOLUTION: For use with automatic syringe. Place the contents of this packet in a standard household measuring container and add water to the 8 3/4 fl. oz. level; or use the measuring container available from your supplier and add water to the mark. Swirl until dissolved. Give 2 ml (milliliter) per 100 lb. body weight. Refer to the table above for the number of cattle this packet will treat. | CONCENTRATED DRENCH SOLUTION: For use with automatic syringe. Place the contents of this packet in a standard household measuring container and add water to the 17 1/2 fl. oz. level. Swirl until dissolved. Give 2 ml per 50 lb. body weight. Refer to the table above for the number of sheep this packet will treat. |
Do not underdose. Ensure each animal receives a complete dose based on a current body weight.
Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
NOTE: Careful weight estimates are essential for proper performance of this product. Prepare solutions
as needed. However, excess solutions may be stored in clean closed containers up to 90 days without
loss of anthelmintic activity. Cattle and Sheep maintained under conditions of constant helminth
exposure may require re-treatment within two to four weeks after the first treatment.
DOSAGE AND ADMINISTRATION: When you are ready to deworm your cattle or sheep, add water to the powder in this bottle up to the 3 liter mark. Swirl to mix thoroughly before using. If any solution is left over, it may be stored for up to 3 months in this tightly capped bottle, shake well before using.
DATE WATER WAS ADDED TO THIS BOTTLE
Month Day Year
Administer as a single drench dose as follows: CATTLE--2 mL per 100 lb. body weight | ||
Weight | Drench dosage | Bottle Will Treat |
100 lb. | 2 mL | 1,500 head |
300 lb. | 6 mL | 500 head |
500 lb. | 10 mL | 300 head |
700 lb. | 14 mL | 214 head |
1,000 lb. | 20 mL | 150 head |
SHEEP--1 mL per 50 lb. body weight | ||
Weight | Drench dosage | Bottle Will Treat |
50 lb. | 1 mL | 3,000 head |
100 lb. | 2 mL | 1,500 head |
150 lb. | 3 mL | 1,000 head |
200 lb. | 4 mL | 750 head |
Do not underdose. Ensure each animal receives a complete dose based on a current body weight.
Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
NOTE: Careful weight estimates are essential for proper performance of this
product. Cattle and sheep maintained under conditions of constant helminth
exposure may require retreatment within two to four weeks after the first
treatment.
Residue Warning
RESIDUE WARNING: Do not administer to cattle within 48 hours of slaughter for food. Do
not administer to sheep within 72 hours of slaughter for food. To prevent residues in milk,
do not administer to dairy animals of breeding age.
RESIDUE WARNING: Do not administer to cattle within 48 hours of slaughter
for food. Do not administer to sheep within 72 hours of slaughter for food. To
prevent residues in milk, do not administer to dairy animals of breeding age.
Warnings
OTHER 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 a 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.
OTHER 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 a 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.
Adverse Reactions
To report suspected adverse drug events, for technical assistance or to
obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc.
at 1-877-994-4883 or www.huvepharma.us. For additional information about
adverse drug experience reporting for animal drugs, contact FDA at
1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
To report suspected adverse drug events, for technical assistance or to
obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at
1-877-994-4883 or www.huvepharma.us. For additional information about
adverse drug experience reporting for animal drugs, contact FDA at
1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Storage And Handling
Store between 20–25°C (68-77°F). MF: L-6232-05 Rev: 03-2022
HOW SUPPLIED: 52 g (1.8 oz) and 605 g (21.34 oz)
LOT EXP.
Store between 20°-25°C (68°-77°F).
HOW SUPPLIED: 52 g (1.8 oz) and 605 g (21.34 oz)
®Registered trademark of Huvepharma, Inc.
Manufactured for
Huvepharma, Inc.
Peachtree City, GA 30269
MF# L-6232-60
Rev. 03-2022
LOT.: EXP. DATE
Package Label.Principal Display Panel
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.