Amoxicillin and Clavulanate Potassium: Product Information (Page 2 of 2)

HOW SUPPLIED:

Amoxicillin and Clavulanate Potassium for Oral Suspension drops are supplied in 22-mL bottles containing 50 mg of amoxicillin/12.5 mg of clavulanic acid per mL.

Approved by FDA under ANADA # 200-604

Augmentin is a trademark owned by GlaxoSmithKline, LLC.

Manufactured for:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Made in Austria.

Rev. November 2020

Dechra

46280398

PRINCIPAL DISPLAY PANEL — 15 mL Vial Carton

Amoxicillin and Clavulanate
Potassium for Oral Suspension

Drops

For veterinary oral suspension
For use in dogs and cats

When reconstituted each mL contains
50 mg of amoxicillin as the trihydrate
and 12.5 mg of clavulanic acid as the
potassium salt.

Do Not Use if Product is Discolored

Caution: Federal (USA) law restricts this
drug to use by or on the order of a
licensed veterinarian.

Approved by FDA under ANADA # 200-604

15 mL

Dechra

Principal Display Panel -- 15 mL Vial Carton
(click image for full-size original)
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium powder, for suspension
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-450
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN 50 mg in 1 mL
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 12.5 mg in 1 mL
Product Characteristics
Color WHITE (White to yellowish) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17033-450-15 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 22 mL in 1 VIAL, GLASS This package is contained within the CARTON (17033-450-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200604 01/01/2022
Labeler — Dechra Veterinary Products LLC (362142734)

Revised: 01/2022 Dechra Veterinary Products LLC

Page 2 of 2 1 2

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2022. All Rights Reserved.