PROHIBIT SOLUBLE DRENCH POWDER- levamisole hydrochloride powder, for solution

PROHIBIT by

Drug Labeling and Warnings

PROHIBIT by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD, Sparhawk Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC: 23243-2320-5
PROHIBIT®
(levamisole hydrochloride)
Soluble Drench Powder
Anthelmintic
Each packet contains 46.8 grams of levamisole hydrochloride activity.

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 longispicularis, Cooperia oncophora, Cooperia punctata,
Nematodirus spathiger, Bunostomum phlebotomum, 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
Made in Bulgaria
®Registered Trademark of Huvepharma, Inc.

LOT

EXP

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.

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.

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.

GENERAL PRECAUTIONS

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.

ADVERSE REACTIONS

CONTACT INFORMATION

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 20–25ºC (68-77ºF).    
HOW SUPPLIED: 52 g (1.8 oz) and 605 g (21.34 oz)

SPL UNCLASSIFIED SECTION

NDC: 23243-2320-6
PROHIBIT®
(levamisole hydrochloride)
Soluble Drench Powder
Anthelmintic

VETERINARY INDICATIONS

CATTLE AND SHEEP DEWORMER FOR ORAL USE
This bottle contains 544.5 grams of levamisole hydrochloride activity.

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 Wt: 21.34 oz (1.3 lb.) (605 g)

VETERINARY INDICATIONS

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 longispicularis, Cooperia oncophora, Cooperia punctata,
Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum.
LUNGWORMS: Dictyocaulus viviparus.

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.

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.

GENERAL PRECAUTIONS

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.

STORAGE AND HANDLING

Store between 20º-25ºC (68º-77ºF).

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
Made in Bulgaria

LOT NO.:                  EXP. DATE

DOSAGE & ADMINISTRATION

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.

ADVERSE REACTIONS

CONTACT INFORMATION

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROHIBIT  SOLUBLE DRENCH POWDER
levamisole hydrochloride powder, for solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 23243-2320
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVAMISOLE HYDROCHLORIDE (UNII: DL9055K809) (LEVAMISOLE - UNII:2880D3468G)	LEVAMISOLE	0.9 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-2320-5	52 g in 1 PACKET
2	NDC: 23243-2320-6	605 g in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200225	04/20/2022

Labeler - Huvepharma, Inc (619153559)

Registrant - Huvepharma EOOD (552671651)