AMOXICILLIN AND CLAVULANATE POTASSIUM (Page 6 of 6)

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 are supplied as follows:

Amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side score line on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows.

Bottles of 20 NDC 76420-005-20 (relabeled from NDC 42571-162-42)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Patients should be informed 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.

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 tablets are 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.

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 tablets contain a penicillin class drug product that can cause allergic reactions in some individuals.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Micro Labs Limited.

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-005(NDC:42571-162) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 875 mg CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE ETHYLCELLULOSE (10 MPA.S) TALC

Product Characteristics Color white (white to off-white) Score 2 pieces Shape CAPSULE (biconvex) Size 22mm Flavor Imprint Code I07 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76420-005-20 20 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204755 03/01/2017

Labeler — Asclemed USA, Inc. (059888437)

Establishment
Name	Address	ID/FEI	Operations
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel (76420-005)

Revised: 09/2020 Asclemed USA, Inc.