Prescription Drug Information: Amoxicillin and Clavulanate Potassium (Page 4 of 4)

15. References

1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.

16. How Supplied/Storage and Handling

Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium).

Bottles of 20 tablets NDC: 80425-0279-01

Bottles of 30 tablets NDC: 80425-0279-02

Dispense in tightly closed, moisture-proof containers. Advise patients to keep in a closed container.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.

17. Patient Counseling and Information

Administration Instructions

Inform patients that amoxicillin and clavulanate potassium tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.

Allergic Reactions

Counsel patients that amoxicillin and clavulanate potassium tablets contains a penicillin class drug product that can cause allergic reactions in some individuals.

Severe Cutaneous Adverse Reactions (SCAR)

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin and clavulanate potassium tablets immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.2)].


Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician as soon as possible.

Antibacterial Resistance

Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When amoxicillin and clavulanate potassium tablet is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium tablets or other antibacterial drugs in the future.

CLINITEST is a registered trademark of Miles, Inc.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited Hyderabad-500 032, India

Revised: 11/2022

label 1label 2

AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0279(NDC:65862-503)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Product Characteristics
Color white ((White to Off-white)) Score 2 pieces
Shape CAPSULE Size 22mm
Flavor Imprint Code X;3;2
# Item Code Package Description Multilevel Packaging
1 NDC:80425-0279-1 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:80425-0279-2 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091568 03/03/2023
Labeler — Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Name Address ID/FEI Operations
Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack (80425-0279)

Revised: 03/2023 Advanced Rx Pharmacy of Tennessee, LLC

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