SPECTOGARD SCOUR-CHEK- spectinomycin solution

SpectoGard Scour-Chek by

Drug Labeling and Warnings

SpectoGard Scour-Chek by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Shandong Qilu King-phar Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Liquid

SpectoGard®
Scour-Chek®
(spectinomycin)

ORAL SOLUTION FOR PIG SCOURS

Anti-infective

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California) – Use Only As Directed

ANADA 200-364, Approved by FDA

INDICATIONS & USAGE

INDICATIONS: For use in pigs under four (4) weeks of age for treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin.

EACH mL CONTAINS: Spectinomycin (from spectinomycin dihydrochloride pentahydrate)...................50 mg

RESIDUE WARNING

RESIDUE WARNINGS: This product is only intended for use in pigs under four (4) weeks of age or weighing less than 15 lbs.
Do not administer within 21 days of slaughter.

STORAGE AND HANDLING

Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted to 15°C - 30°C (59°F - 86°F).

DOSAGE & ADMINISTRATION

DOSE: Pigs under 10 lbs. - 1 pump (1 mL) twice daily.

Pigs over 10 lbs. - 2 pumps (2 mL) twice daily.

Each pump of the plunger delivers 1 mL of solution containing 50 mg of spectinomycin. Treatment may be continued twice daily for 3 to 5 days. If pigs do not improve within 48 hours, rediagnosis is suggested.

DIRECTIONS FOR USE: The plastic doser supplied in each package with SpectoGard® Scour-Chek® makes treatment easy. After inserting the doser in the bottle, screw the top on tightly to avoid spilling. Push the piece of clear plastic tubing over the end of the pump. Then press the plunger a few times to fill the pump and the clear plastic tube with medication. To administer SpectoGard® Scour-Chek®, insert the plastic tube in the pig's mouth and press the plunger to obtain the desired dose.

When not in use remove the plunger from the bottle. Put the clear plastic tube in the neck of the bottle and press the plunger a few times to remove the medication from the pump. Replace the original cap on the bottle and always rinse out the doser with water to prevent sticking.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPECTOGARD SCOUR-CHEK 
spectinomycin solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-6002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Spectinomycin (UNII: 93AKI1U6QF) (Spectinomycin - UNII:93AKI1U6QF)	Spectinomycin	50 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-6002-5	3785 mL in 1 BOTTLE
2	NDC: 61133-6002-7	1000 mL in 1 BOTTLE
3	NDC: 61133-6002-6	240 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200364	07/09/2004

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Qilu King-phar Parmaceutical Co., Ltd.		421524323	api manufacture