LINCOMYCIN-SPECTINOMYCIN WATER SOLUBLE POWDER- lincomycin-spectinomycin powder, for solution

Lincomycin-Spectinomycin by

Drug Labeling and Warnings

Lincomycin-Spectinomycin by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD, Sparhawk Laboratories, Inc., Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd., HEC PHARM CO., LTD. The Second Site. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LINCOMYCIN-SPECTINOMYCIN

WATER SOLUBLE POWDER
Antibacterial and Antimycoplasmal

GENERAL PRECAUTIONS

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

FOR USE IN CHICKENS ONLY

DOSAGE & ADMINISTRATION

This packet contains:
Lincomycin hydrochloride, equivalent to lincomycin ...... 16.7 grams
Spectinomycin dihydrochloride pentahydrate,
                        equivalent to spectinomycin.................33.3 grams
  Total Antibiotic Activity             50.0 grams

Approved by FDA under ANADA # 200-407
NET WEIGHT: 2.65 oz (75 grams)

® Registered Trademark of Huvepharma, Inc

INDICATIONS & USAGE

                                                            DIRECTIONS FOR USE
INDICATIONS AND USAGE: For use in chickens up to 7 days of age as an aid in the control of:
Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin.

Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible
to lincomycin-spectinomycin.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION
Dosage: Provide 2 grams (g) antibiotic activity per gallon of drinking water. Administer as the sole source of water for the first 5 to 7 days of life.

Administration:

Amount of Lincomycin-Spectinomycin	Amount of Drinking Water
1 packet	25 gallons
For proportioners delivering 1 ounce of solution per gallon of drinking water,; dissolve contents of 5 packets in each gallon of proportioner solution.

IMPORTANT: Chickens should consume water at the following approximate rate to ensure intake of the required dose of lincomycin-spectinomycin indicated:

Broilers and Layer Replacements (Light and Heavy)
Age; (Weeks)	Daily Water Intake; (Gallons/1000)	Dosage; (mg Antibiotic/lb)
1	5	50-65

GENERAL PRECAUTIONS

PRECAUTION: Discard medicated drinking water daily and replace with fresh medicated drinking water.

USER SAFETY WARNINGS

WARNING:    Not for Human Use
                     Keep Out of Reach of Children

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

Restricted Drug (California) - Use Only as Directed
Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F)

SPL UNCLASSIFIED SECTION

Manufactured For:
Huvepharma, Inc. Peachtree City, GA 30269

® Registered Trademark of Huvepharma, Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LINCOMYCIN-SPECTINOMYCIN  WATER SOLUBLE POWDER
lincomycin-spectinomycin powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-4240
Route of Administration	Oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)	LINCOMYCIN	16.7 g  in 75 g
SPECTINOMYCIN HYDROCHLORIDE (UNII: HWT06H303Z) (SPECTINOMYCIN - UNII:93AKI1U6QF)	SPECTINOMYCIN	33.3 g  in 75 g

Inactive Ingredients
Ingredient Name	Strength
Sucrose (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-4240-2	75 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200407	11/01/2022

Labeler - Huvepharma, Inc (619153559)

Registrant - Huvepharma EOOD (552671651)