Lincomix

Dosage Form: FOR ANIMAL USE ONLY
Lincomix®

Soluble Powder

lincomycin hydrochloride

(agricultural grade) soluble powder

Antibacterial

SWINE: Directions for Use

Indications and Usage for Lincomix

Lincomix Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).

Lincomix 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 pound 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 grams lincomycin per ton of complete feed as the sole ration according to label directions.

Administration

This bottle will medicate 768 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per pound 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 one bottle in six gallons of water: then adjust the proportioner to deliver 1 ounce 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

Indications and Usage for Lincomix

Lincomix Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.

Lincomix 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. If improvement is not noted within 24 to 48 hours, consult a licensed veterinarian or veterinary diagnostic laboratory to determine diagnosis. The drug should be administered for 7 consecutive days.

Administration

This bottle 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

1. Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. 2. 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. 3. Occasionally, swine fed lincomycin may within the first two 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 five to eight days without discontinuing the lincomycin treatment. 4. The safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding. 5. 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. 6. Do not use the water treatment and the feed treatment simultaneously. 7. Not for use in layer and breeder chickens.

Warnings

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


2. Not for human use.

Store at Controlled Room Temperature 20° to 25° C (68 ° to 77° F).

Restricted Drug (California)-Use Only as Directed

Made in China

Dist. by: Pharmacia & Upjohn Co., Div. of Pfizer Inc, New York, NY 10017

1453000

A73168-1

PRINCIPAL DISPLAY PANEL - 480 gram Bottle

Lincomix®

Soluble Powder

lincomycin hydrochloride

(agricultural grade) soluble powder

Antibacterial

FOR ORAL USE IN SWINE AND

BROILER CHICKENS ONLY

This bottle cotains as active ingredient:

Lincomycin hydrochloride,

equivalent to lincomycin . . . . 192 grams

NADA #111-636, Approved by FDA

Pfizer

PEEL FROM THE RIGHT

FOR SPANISH LANGUAGE

TAKE TIME

OBSERVE LABEL

DIRECTIONS

NET WT. 16.92 OZ

(480 GRAMS)

Lincomix  lincomycin hydrochloride  powder, for solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 0009-0962 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINCOMYCIN HYDROCHLORIDE (Lincomycin) Lincomycin 64 g  in 160 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-0962-35 160 g In 1 BOTTLE, PLASTIC None 2 0009-0962-36 480 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA111636	01/28/1983

Labeler - Pharmacia and Upjohn Company (829076566)

Establishment
Name	Address	ID/FEI	Operations
Pharmacia and Upjohn Company		829076566	API MANUFACTURE, MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pfizer Suzhou Animal Health Products Company Ltd		546995361	MANUFACTURE

Revised: 11/2009Pharmacia and Upjohn Company