Amoxicillin (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.
  • 2.Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  • 3.Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
  • 4.Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement , CLSI document M100-S25. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amoxicillin Capsules, USP, for oral administration, contain 250 mg or 500 mg amoxicillin as the trihydrate and are supplied as:

250 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 250 on one side and GG 848 on the other side.

NDC 70882-113-30, Package of 30 tablets (3 x 10 unit-of-dose blisters)

500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side.

NDC 70882-114-20, Package of 20 tablets (2 x 10 unit-of-dose blisters)

Store capsules at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.

17 PATIENT COUNSELING INFORMATION

Information for Patients

  • Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
  • Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin 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 or other antibacterial drugs in the future.
  • Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.
  • Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.
    CLINITEST® is a registered trademark of Miles, Inc.
    CLINISTIX® is a registered trademark of Bayer Corporation.
    CLOtest® is a registered trademark of Kimberly-Clark Corporation.

11/2016

Manufactured by Sandoz GmbH Austria
Product of Spain

Distributed by Cambridge Therapeutic Technologies, LLC
Teaneck, NJ 07666

Package by Legacy Pharmaceutical Packaging, LLCEarth City, MO 63045

20542

250 mg Capsule Label

Amoxicillin Capsules, USP 250mg
(click image for full-size original)

NDC 70882-113-30

Amoxicillin

Capsules,

USP

250 mg

Rx only

30 Capsules

500 mg Capsule Label

Amoxicillin Capsules, USP 500mg
(click image for full-size original)

NDC 70882-114-20

Amoxicillin

Capsules,

USP

500 mg

Rx only

30 Capsules

AMOXICILLIN amoxicillin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-113(NDC:0781-2020)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
AMMONIA
POTASSIUM HYDROXIDE
WATER
ALCOHOL
Product Characteristics
Color YELLOW (Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AMOX;250;GG;848
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-113-30 30 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064076 09/30/1994
AMOXICILLIN amoxicillin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-114(NDC:0781-2613)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
AMMONIA
POTASSIUM HYDROXIDE
WATER
ALCOHOL
Product Characteristics
Color YELLOW (Opaque) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AMOX;500;GG;849
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-114-20 20 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064076 09/30/1994
Labeler — Cambridge Therapeutics Technologies, LLC (080072003)

Revised: 12/2016 Cambridge Therapeutics Technologies, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.