Label: ALBON BOLUS- sulfadimethoxine tablet
- NDC Code(s): 54771-8449-1, 54771-8450-1, 54771-8450-2
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated June 8, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- CAUTION
- DESCRIPTION
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Actions
Sulfadimethoxine has been demonstrated in laboratory studies to be effective against a wide variety of organisms, such as streptococci, staphylococci, and members of the E. coli-salmonella group of bacteria.
Comparatively low doses of Albon give rapid, sustained blood levels required for effective disease therapy.
- INDICATIONS AND USAGE
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WARNINGS
Not for Human Use
Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food.
Do not slaughter animals for food purposes within 7 days following the last treatment.
A withdrawal period has not been established for this product in preruminating calves.
Do Not Use in Calves to be Processed for Veal
- PRECAUTIONS
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DOSAGE AND ADMINISTRATION
Albon should be administered to cattle so that the initial dose is equivalent to 25 mg/lb of body weight and each subsequent daily dose is equivalent to 12.5 mg/lb of body weight. Length of treatment will depend on clinical response. In most cases, treatment for 3–4 days is adequate. Treatment should not be continued beyond 5 days.
The following tables show the dosage and dosage forms to be used for cattle of different weights.
- TOXICITY AND SAFETY
- STORAGE AND HANDLING
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 g - 50 Bolus Bottle Label
- PRINCIPAL DISPLAY PANEL - 15 g - 12 Bolus Bottle Label
- PRINCIPAL DISPLAY PANEL - 15 g - 50 Bolus Bottle Label
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INGREDIENTS AND APPEARANCE
ALBON BOLUS
sulfadimethoxine tabletProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8449 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfadimethoxine (UNII: 30CPC5LDEX) (sulfadimethoxine - UNII:30CPC5LDEX) sulfadimethoxine 5 g Product Characteristics Color white (White to Off White) Score 2 pieces Shape OVAL (Oblong, biconvex bolus) Size 35mm Flavor Imprint Code Albon;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-8449-1 50 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA031715 04/12/1968 ALBON BOLUS
sulfadimethoxine tabletProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8450 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfadimethoxine (UNII: 30CPC5LDEX) (sulfadimethoxine - UNII:30CPC5LDEX) sulfadimethoxine 15 g Product Characteristics Color white (White to Off White) Score 2 pieces Shape OVAL (Oblong, biconvex bolus) Size 53mm Flavor Imprint Code Albon;15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-8450-1 12 in 1 BOTTLE, PLASTIC 2 NDC:54771-8450-2 50 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA031715 04/12/1968 Labeler - Zoetis Inc. (828851555)