Amoxicillin and Clavulanate Potassium (Page 7 of 7)

17.1 Information for Patients

Patients should be informed that amoxicillin and clavulanate potassium 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.

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

Patients should be advised to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of amoxicillin and clavulanate potassium may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.

Patients should be aware that amoxicillin and clavulanate potassium contains a penicillin class drug product that can cause allergic reactions in some individuals.

CLINITEST is a registered trademark of Miles, Inc.

Manufactured by Lek Pharmaceuticals d.d.
Slovenia

Distributed by Cambridge Therapeutic Technologies, LLC
Teaneck, NJ 07666

Packaged by Legacy Pharmaceutical Packaging, LLC
Earth City, MO 63045

12-2016
20627

PRINCIPAL DISPLAY PANEL

NDC 70882-112-20

Amoxicillin and Clavulanate Potassium Tablets, USP

500 mg/125 mg

Rx only

20 tablets

Amoxicillin and Clavulanate Potassium Tablets, USP 500mg/125mg
(click image for full-size original)
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin and clavulanate potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-112(NDC:66685-1002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code 500125;AMC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-112-20 20 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065117 11/27/2002
Labeler — Cambridge Therapeutics Technologies, LLC (080072003)

Revised: 01/2017 Cambridge Therapeutics Technologies, LLC

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