17 PATIENT COUNSELING INFORMATION
17.1 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 Siemens Medical Solutions Diagnostics, and Ames Company, Inc.
CLINISTIX® is a registered trademark of Bayer Healthcare Llc, and Ames Company, Inc.
CLOtest® is a registered trademark of Kimberly-Clark Worldwide, Inc.
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Aurobindo Pharma Limited
Hyderabad-500 072, India
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 875 mg (100 Tablet Bottle)
Amoxicillin Tablets, USP
Rx only 100 Tablets
| AMOXICILLIN amoxicillin tablet, film coated |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:66116-477(NDC:65862-015) |
|Route of Administration ||ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|AMOXICILLIN (AMOXICILLIN ANHYDROUS) ||AMOXICILLIN ANHYDROUS ||875 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| SILICON DIOXIDE || |
| CROSPOVIDONE || |
| D&C RED NO. 30 || |
| HYPROMELLOSE 2910 (6 MPA.S) || |
| HYPROMELLOSE 2910 (15 MPA.S) || |
| MAGNESIUM STEARATE || |
| CELLULOSE, MICROCRYSTALLINE || |
| POLYETHYLENE GLYCOL 3350 || |
| POLYETHYLENE GLYCOL 8000 || |
| SODIUM STARCH GLYCOLATE TYPE A POTATO || |
| TITANIUM DIOXIDE || |
|Product Characteristics |
|Color ||PINK ||Score ||2 pieces |
|Shape ||OVAL (CAPSULE-SHAPED) ||Size ||21mm |
|Flavor || ||Imprint Code ||A;6;7 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:66116-477-20 ||20 TABLET, FILM COATED in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA065256 ||11/09/2005 || |
|Labeler — MedVantx, Inc.
|Registrant — Aurobindo Pharma Limited (650082092) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Blenheim Pharmacal, Inc. || ||171434587 ||REPACK (66116-477) |
Revised: 03/2013 MedVantx, Inc.
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