Label: LINCOMYCIN HYDROCHLORIDE powder, for solution
- NDC Code(s): 23243-6752-1, 23243-6752-2, 23243-6752-3
- Packager: Huvepharma, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated April 26, 2023
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- Official Label (Printer Friendly)
- 80 Gram Packet Front Panel
- SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
-
VETERINARY INDICATIONS
For Oral Use in Swine and Broiler Chickens Only
Not for use in layer and breeder chickens
Keep Out of Reach of ChildrenINDICATIONS 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. -
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. -
RESIDUE WARNING
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. - SPL UNCLASSIFIED SECTION
-
DOSAGE & ADMINISTRATION
SWINE: Directions for use
DOSAGE AND ADMINISTRATIONDosage: 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. -
DOSAGE & ADMINISTRATION
BROILER CHICKENS: Directions for use
DOSAGE AND ADMINISTRATIONDosage: 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
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
- GENERAL PRECAUTIONS
- STORAGE AND HANDLING
-
INDICATIONS & USAGE
For Oral Use in Swine and Broiler Chickens Only
Not for use in layer or breeder chickens
Keep Out of Reach of Children
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. -
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. -
RESIDUE WARNING
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. - SPL UNCLASSIFIED SECTION
-
DOSAGE & ADMINISTRATION
SWINE: Directions for use
DOSAGE AND ADMINISTRATIONDosage: 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. -
DOSAGE & ADMINISTRATION
BROILER CHICKENS: Directions for use
DOSAGE AND ADMINISTRATIONDosage: 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 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
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
- PRECAUTIONS
- STORAGE AND HANDLING
-
VETERINARY INDICATIONS
For Oral Use in Swine and Broiler Chickens Only
Not for use in layer and breeder chickens
Keep Out of Reach of ChildrenINDICATIONS 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. -
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. -
RESIDUE WARNING
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. - SPL UNCLASSIFIED SECTION
-
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. -
SPL UNCLASSIFIED SECTION
BROILER CHICKENS: Directions for use
DOSAGE AND ADMINISTRATIONDosage: 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
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 HYDROCHLORIDE
lincomycin hydrochloride powder, for solutionProduct 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 (552671651) Establishment Name Address ID/FEI Business Operations Huvepharma, Inc - St. Louis 883128204 analysis, label, manufacture, medicated animal feed manufacture, pack