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

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