Label: ALBON BOLUS- sulfadimethoxine tablet

  • NDC Code(s): 54771-8449-1, 54771-8450-1, 54771-8450-2
  • Packager: Zoetis Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 7, 2019

If you are a consumer or patient please visit this version.

  • 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

    Figure
  • 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
    2001 bolus1/2 bolus
    3001 1/2 boluses1 bolus
    4002 boluses1 bolus
    5002 1/2 boluses1 1/2 boluses
    6003 boluses1 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
    6001 bolus1/2 bolus
    8001 1/2 boluses1 bolus
    1,000-1,2002 boluses1 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

    5g 50ct bottle label
  • PRINCIPAL DISPLAY PANEL - 15 g - 12 Bolus Bottle Label

    15g 12ct bottle label
  • PRINCIPAL DISPLAY PANEL - 15 g - 50 Bolus Bottle Label

    15g 50ct bottle label
  • INGREDIENTS AND APPEARANCE
    ALBON  BOLUS
    sulfadimethoxine tablet
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-8449
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sulfadimethoxine (UNII: 30CPC5LDEX) (sulfadimethoxine - UNII:30CPC5LDEX) sulfadimethoxine5 g
    Product Characteristics
    ColorWHITE (White to Off White) Score2 pieces
    ShapeOVAL (Oblong, biconvex bolus) Size35mm
    FlavorImprint Code Albon;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-8449-150 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03171504/12/1968
    ALBON  BOLUS
    sulfadimethoxine tablet
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-8450
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sulfadimethoxine (UNII: 30CPC5LDEX) (sulfadimethoxine - UNII:30CPC5LDEX) sulfadimethoxine15 g
    Product Characteristics
    ColorWHITE (White to Off White) Score2 pieces
    ShapeOVAL (Oblong, biconvex bolus) Size53mm
    FlavorImprint Code Albon;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-8450-112 in 1 BOTTLE, PLASTIC
    2NDC:54771-8450-250 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03171504/12/1968
    Labeler - Zoetis Inc. (828851555)