Amoxicillin (Page 5 of 5)
15 REFERENCES
- 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 Capsules, USP 500 mg are available as ivory cap and ivory body. The cap of the 500 mg capsule is imprinted with West-ward and the body with 939.
500 mg Capsule
Bottles of 500 NDC 72789-225-82
Store at 20°-25°C (68°-77°F) [ See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
• Patients should be advised that amoxicillin capsules may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
• Patients should be counseled that antibacterial drugs, including amoxicillin capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin capsules 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 capsules 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 capsules contains a penicillin class drug product that can cause allergic reactions in some individuals.
Distributed by:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724 USA
Manufactured by :
Hikma Pharmaceuticals
P.O. Box 182400
Amman 11118 – Jordan
Revised February 2019
Amoxicillin Capsules, USP 500 mg
| AMOXICILLIN amoxicillin capsule | ||||||||||||||||||
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| Labeler — PD-Rx Pharmaceuticals, Inc. (156893695) |
| Registrant — PD-Rx Pharmaceuticals, Inc. (156893695) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| PD-Rx Pharmaceuticals, Inc. | 156893695 | repack (72789-225) | |
Revised: 03/2023 PD-Rx Pharmaceuticals, Inc.
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