Storage and handling
Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted 15°C - 30°C (59°F - 86°F).
SpectoGard Water Soluble Powder
- Manufacturer
- Bimeda, Inc.
- Effective date
- 2023-12-06
- Label type
- PRESCRIPTION ANIMAL DRUG LABEL
- Version
- 16
- Source
- full-release
- Hydrated at
- 2026-06-01 02:42:36
Label at a glance#
ProductSpectoGard Water Soluble Powder
Active ingredientSPECTINOMYCIN
Label structure7 sections
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/reportanimalae
www.fda.gov/reportanimalaeLabel contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
SpectoGard® Water Soluble Powder
(spectinomycin)
FOR GROWING CHICKENS
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 NADA # 038-661
INDICATIONS & USAGE SECTION
INDICATIONS, DOSAGE AND ADMINISTRATION:
As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO). Administer two (2) grams per gallon of water as the only source of drinking water for the first three days of life and for one day following each vaccination.
As an aid in controlling infectious synovitis due to Mycoplasma synoviae in broiler chickens. Administer one (1) gram per gallon of water as the only source of drinking water for the first three to five days of life.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS FOR USE:
To provide 2 g/gal: Dissolve contents in 250 gallons of water. For proportioners, dissolve contents of 1/2 package in 1 gallon of water. Meter at 1 oz/gal.
To provide 1 g/gal: Dissolve contents in 500 gallons of water. For proportioners, dissolve contents of 1/2 package in 2 gallons of water. Meter at 1 oz/gal.
RESIDUE WARNING SECTION
RESIDUE WARNING: DO NOT administer this drug within 5 days of slaughter. DO NOT administer to laying chickens.
PRECAUTIONS SECTION
PRECAUTION:
Rarely, some individuals who handle spectinomycin develop serious reactions involving skin, nails and eyes. Individuals who have experienced rash or other evidence of allergic reaction should avoid further contact with spectinomycin.
The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
STORAGE AND HANDLING SECTION
Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted 15°C - 30°C (59°F - 86°F).
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61133-5485-1 | SpectoGard Water Soluble Powder | 1000 g in 1 CANISTER | POWDER, FOR SOLUTION | 1000 | 16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61133-5485 | SPECTOGARD WATER SOLUBLE POWDER (SPECTINOMYCIN) POWDER, FOR SOLUTION [BIMEDA, INC.] | 16 | 1 package rows | 20231207_e161433d-baa9-4e29-b2ee-232ea40d7756.zip |
Products#
Every source-derived product name is available through these pages.
- SpectoGard Water Soluble Powder
- spectinomycin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61133-5485 | 61133-5485-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SPECTINOMYCIN | 93AKI1U6QF | ACTIB |
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.