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, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

NDC 62135‐462‐20 bottle of 20 film coated tablets

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 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)].

Diarrhea

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.

Manufactured for:

Chartwell RX, LLC

Congers, NY 10920

L71337

Rev. 02/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amoxicillin and Clavulanate Potassium Tablets, USP 500 mg/125 mg- NDC 62135-462-20 — 20s-Bottle-Label

image description
(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:62135-462
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
MICROCRYSTALLINE CELLULOSE
CETYL ALCOHOL
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color white Score no score
Shape OVAL Size 21mm
Flavor Imprint Code GGN6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-462-20 20 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065064 08/01/2022
Labeler — Chartwell RX, LLC (079394054)

Revised: 03/2023 Chartwell RX, LLC

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