ALBON BOLUS- sulfadimethoxine tablet

Albon by

Drug Labeling and Warnings

Albon by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ALBON®
(sulfadimethoxine)

Boluses

DESCRIPTION

Albon is a low-dose, rapidly absorbed, long-acting sulfonamide.

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

Albon is effective in the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine in cattle.

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

During treatment period, make certain that animals maintain adequate water intake.

If animals show no improvement within 2–3 days, reevaluate your diagnosis. Treatment should not be continued beyond 5 days.

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.

Albon Boluses, 5 g

Dosage Schedule for Cattle: 200–600 lb of body weight

Animal Weight, lb	First Day	Daily for the Following 3–4 Days
200	1 bolus	1/2 bolus
300	1 1/2 boluses	1 bolus
400	2 boluses	1 bolus
500	2 1/2 boluses	1 1/2 boluses
600	3 boluses	1 1/2 boluses

Albon Boluses, 15 g

Dosage Schedule for Cattle: 600–1,200 lb of body weight

Animal Weight, lb	First Day	Daily for the Following 3–4 Days
600	1 bolus	1/2 bolus
800	1 1/2 boluses	1 bolus
1,000-1,200	2 boluses	1 bolus

TOXICITY AND SAFETY

Albon has been shown to be a well-tolerated sulfonamide with relatively high solubility at the pH normally occurring in the kidney and with a low degree of tox- icity. Following the administration of Albon at the recommended dosage, no undesirable side effects have been observed.

STORAGE AND HANDLING

Store at Controlled Room Temperature 15°–30°C (59°–86°F)

HOW SUPPLIED

Albon Boluses are supplied in the following dosage forms:

5 g sulfadimethoxine per single-scored bolus

15 g sulfadimethoxine per single-scored bolus

SPL UNCLASSIFIED SECTION

Restricted Drug (California)—Use Only as Directed

Approved by FDA under NADA # 031-715

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40028043
Revised: May 2019

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

INGREDIENTS AND APPEARANCE

ALBON  BOLUS
sulfadimethoxine tablet

Product Information
Product Type	OTC 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 tablet

Product Information
Product Type	OTC 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)