LINCOMYCIN- lincomycin hydrochloride powder, for solution

Lincomycin Hydrochloride by

Drug Labeling and Warnings

Lincomycin Hydrochloride by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD, Huvepharma, Inc - Longmont, Huvepharma, Inc - St. Louis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

80 Gram Packet Front Panel

Lincomycin Hydrochloride Soluble Powder
Antibacterial

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 32 g lincomycin

Net Weight

80 grams
(2.82 oz)

Huvepharma®

Manufactured for:
Huvepharma, Inc.
525 Westpark Drive, Suite 230 
Peachtree City, GA 30269

Restricted Drug (California) - Use only as directed.
Not for Human Use. 

ANADA 200-189, Approved by FDA 

P08-3902BF (04-2018)

Storage

Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted between 15˚C - 40˚C (59˚F - 104˚F).

See back for instructions.

INDICATIONS AND USAGE:

Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).

Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.

RESIDUE WARNINGS

No drug withdrawal period is required before slaughter of swine receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 250 mg per gallon of drinking water, nor before slaughter of birds receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 64 mg per gallon of drinking water.

Swine: Directions for use DOSAGE AND ADMINISTRATION

Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In
clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per lb of body
weight per day.
Treatment Period: The drug should be administered for a minimum of 5 consecutive days
beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive
days. If water treatment is discontinued prior to this time, a lincomycin treatment program may
be continued with lincomycin premix at 100 g lincomycin per ton of complete feed as the sole
ration according to label directions.
Administration: This packet will medicate 128 gallons of drinking water providing 250 mg/gallon.
A dose of 3.8 mg lincomycin per lb of body weight may be maintained by medicating the
drinking water at a concentration of 250 mg per gallon of drinking water when pigs are
consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the
concentration of lincomycin required in medicated water may be adjusted to compensate for
variations in age and weight of animals, the nature and severity of disease symptoms,
environmental temperature and humidity, each of which affects water consumption. For use in
automatic water proportioners, prepare the stock solution by dissolving 1 packet in 1 gallon of
water: then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking water.
Note: After a treatment program is discontinued, a control program for swine dysentery may be followed
by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration. 

Broiler Chickens: Directions for use DOSAGE AND ADMINISTRATION

Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug
should be administered for 7 consecutive days.
Administration: This packet will medicate 500 gallons of drinking water providing 64 mg/gallon.
Note: After water medication is discontinued, a control program for necrotic enteritis may be followed by
feeding lincomycin premix at 2 grams lincomycin per ton of complete feed.

PRECAUTIONS

Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do
not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea
pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in
severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first
6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin
may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare
occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been
self-correcting within 5 to 8 days without discontinuing the lincomycin treatment. The safety of lincomycin has
not been demonstrated for pregnant swine or swine intended for breeding.
Chickens: Not for use in layer and breeder chickens.

160 Gram Front Panel

Lincomycin Hydrochloride Soluble Powder
Antibacterial

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 64 g lincomycin

For Oral Use in Swine and Broiler Chickens Only

Not for use in layer or breeder chickens

Keep Out of Reach of Children

Net Weight
160 grams
(5.64 oz)

Huvepharma®

Manufactured for:

Huvepharma, Inc.

525 Westpark Drive, Suite 230
Peachtree City, GA 30269 

Restricted Drug (California) - Use only as directed.
Not for Human Use.

ANADA 200-189, Approved by FDA

P08-3903BF (04-2018)

Storage

Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted
between 15˚C - 40˚C (59˚F - 104˚F). See back for instructions.

INDICATIONS AND USAGE:

Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours)

Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.

RESIDUE WARNINGS:

No drug withdrawal period is required before slaughter of swine receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 250 mg per gallon of drinking water, nor before slaughter of birds receiving Lincomycin Hydrochloride Soluble Powder at the approved level of 64 mg per gallon of drinking water.

SWINE: Directions for use DOSAGE AND ADMINISTRATION

Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies,
this dose rate provided an average of 3.8 mg of lincomycin per lb of body weight per day.
Treatment Period: The drug should be administered for a minimum of 5 consecutive days beyond the
disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is
discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at
100 g lincomycin per ton of complete feed as the sole ration according to label directions.
Administration: This packet will medicate 256 gallons of drinking water providing 250 mg/gallon. A dose of
3.8 mg lincomycin per lb of body weight may be maintained by medicating the drinking water at a
concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of
body weight per day. Under these circumstances the concentration of lincomycin required in medicated water
may be adjusted to compensate for variations in age and weight of animals, the nature and severity of
disease symptoms, environmental temperature and humidity, each of which affects water consumption. For
use in automatic water proportioners, prepare the stock solution by dissolving 1 packet in 2 gallons of water:
then adjust the proportioner to deliver 1 oz of stock solution per gallon of drinking water.
Note: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin
premix at 40 grams lincomycin per ton of complete feed as the sole ration. 

Broiler Chickens: Directions for use DOSAGE AND ADMINISTRATION

Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7consecutive days.
Administration: This packet will medicate 1000 gallons of drinking water providing 64 mg/gallon.
Note: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2
grams lincomycin per ton of complete feed. 

PRECAUTIONS

Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the water treatment and

the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin.
Ingestion by these species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment. The safety of lincomycin has not been
demonstrated for pregnant swine or swine intended for breeding.
Chickens: Not for use in layer and breeder chickens.

480 Gram Front Panel

Lincomycin Hydrochloride Soluble Powder
Antibacterial

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

This packet contains as an active ingredient:
Lincomycin HCl, equivalent to 192 g lincomycin

Net Weight

480 grams
(16.92 oz)

Huvepharma®

Manufactured for:
Huvepharma, Inc.
525 Westpark Drive, Suite 230
Peachtree City, GA 30269

Restricted Drug (California) - Use only as directed.
Not for Human Use.

ANADA 200-189, Approved by FDA

P08-3904BF

KLA-N00004 (03-2018)

Storage

Store between 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted
between 15˚C - 40˚C (59˚F - 104˚F). See back for instructions.

INDICATIONS AND USAGE:

Swine: Lincomycin Hydrochloride Soluble Powder is indicated
for the treatment of swine dysentery (bloody scours).
Broiler Chickens: Lincomycin Hydrochloride Soluble Powder is
indicated for the control of necrotic enteritis caused by Clostridium
perfringens susceptible to lincomycin.

RESIDUE WARNINGS:

No drug withdrawal period is required before slaughter of
swine receiving Lincomycin Hydrochloride Soluble Powder at
the approved level of 250 mg per gallon of drinking water, nor
before slaughter of birds receiving Lincomycin Hydrochloride
Soluble Powder at the approved level of 64 mg per gallon of
drinking water.

SWINE: Directions for use DOSAGE AND ADMINISTRATION

Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an
average of 3.8 mg of lincomycin per lb of body weight per day.
Treatment Period: The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms
(bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin
treatment program may be continued with lincomycin premix at 100 g lincomycin per ton of complete feed as the sole ration
according to label directions.
Administration: This packet will medicate 768 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per lb
of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when
pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin
required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of
disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water
proportioners, prepare the stock solution by dissolving 1 packet in 6 gallons of water: then adjust the proportioner to deliver 1 oz
of stock solution per gallon of drinking water.
Note: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin
premix at 40 grams lincomycin per ton of complete feed as the sole ration.

Broiler Chickens: Directions for use DOSAGE AND ADMINISTRATION

Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.
Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7
consecutive days.
Administration: This packet will medicate 3000 gallons of drinking water providing 64 mg/gallon.
Note: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin premix at 2
grams lincomycin per ton of complete feed.

PRECAUTIONS:

Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the water
treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water
containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.
Swine: If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication,
discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 days after the onset of
treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable
behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment. The safety of
lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.
Chickens: Not for use in layer and breeder chickens.

80 GRAM Packet Label Image

160 GRAM Packet Label Image

480 GRAM Packet Label Image

INGREDIENTS AND APPEARANCE

LINCOMYCIN 
lincomycin hydrochloride powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-6752
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	0.4 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-6752-1	25 in 1 PAIL
1		80 g in 1 PACKET
2	NDC: 23243-6752-2	20 in 1 PAIL
2		160 g in 1 PACKET
3	NDC: 23243-6752-3	25 in 1 PAIL
3		480 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200189	04/13/2017

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc - Longmont		080346321	manufacture, analysis, pack, label