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Therabloat

Therabloat

Approved
Approval ID

30d68d51-58a9-4754-a211-6991cda91263

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Zoetis Inc.

DUNS: 828851555

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

poloxalene

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54771-8620
Application NumberNADA039729
Product Classification
M
Marketing Category
C73593
G
Generic Name
poloxalene
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (1)

POLOXALENEActive
Quantity: 25 g in 30 mL
Code: V8B3K56SW0
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PRINCIPAL DISPLAY PANEL - 2 fl oz (59.1 mL) label

label

40051846

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/23/2025

For Animal Use Only

Not for Human Use

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40039268

VETERINARY INDICATIONS SECTION

LOINC: 50745-9Updated: 5/23/2025

Indications

Therabloat Drench Concentrate will relieve legume bloat in cattle within minutes when used as directed. For best results administer at the earliest sign of bloat. If bloat has progressed in its severity to the degree that the animal is down, other means of treatment also are recommended (rumenotomy- rumen puncture). For oral use only—not for injection. May be used in lactating animals.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Dosage

For animals up to 500 lb, use 1 fl oz of Drench Concentrate. For animals over 500 lb, use 2 fl oz of Drench Concentrate.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/23/2025

Storage

Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° and 37°C (59° and 99°F).

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Therabloat - FDA Drug Approval Details