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AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE- amoxicillin and clavulanate potassium tablet, film coated, extended release

  1. Patient Information
  2. Manufactured By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 Information for Patients

Counsel patients to take Amoxicillin and Clavulanate Potassium Extended Release Tablets every 12 hours with a low fat meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor.

Patients should be counseled that antibacterial drugs, including Amoxicillin and Clavulanate Potassium Extended Release 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 Extended Release 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 Extended Release Tablets or other antibacterial drugs in the future.

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. Discard any unused medicine.

Patients should be aware that Amoxicillin and Clavulanate Potassium Tablets contain a penicillin class drug product that can cause allergic reactions in some individuals.

AUGMENTIN XR and AUGMENTIN are registered trademarks of GlaxoSmithKline and are licensed to Dr. Reddy's Laboratories, Inc.

MAALOX is a registered trademark of Novartis Consumer Health, Inc.

CLINITEST is a registered trademark of Miles, Inc.

Manufactured By: 

Dr. Reddy's Laboratories Tennessee LLC,

Bristol, TN 37620

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