Animal NDC 61133-6002-6 Spectogard Scour-chek
Spectinomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-6002-6
Proprietary Name Spectogard Scour-chek What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Spectinomycin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Bimeda, Inc.
Product Type Prescription Animal Drug
Usage Information
    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
Active Ingredient(s)
  • Spectinomycin
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200364 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Spectogard Scour-chek Images

Spectogard Scour-chek Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Liquid
SpectoGard®
Scour-Chek®
(spectinomycin)
ORAL SOLUTION FOR PIG SCOURS
Anti-infective
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) – Use Only As Directed
Approved by FDA under ANADA # 200-364


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



240 mL:
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.

1000 mL/1 Gallon:
DIRECTIONS FOR USE: The 1000 mL/1 Gallon bottle of SpectoGard Scour-Chek should be used only to refill the 240 mL bottle in the following manner.
1. Remove the cap and doser from the 240 mL bottle.
2. Unscrew the cap from the 1000 mL/1 Gallon bottle.
3. Pour, from the 1000 mL/1 Gallon bottle, the volume desired.
4. Reinsert the doser in the 240 L bottle and screw the cap on tightly.
5. Screw the cap tightly on the 1000 mL/1 Gallon bottle.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.