Product Information
NDC: 16714-299-03
Amoxicillin 500 mg Capsules, 100 Count — Northstar Rx
| Product Details | Description |
|---|---|
| Active ingredient | Amoxicillin 500 mg (as amoxicillin trihydrate) |
| Dosage form | Capsule |
| Route | Oral |
| Size | 100 capsules |
| Manufacturer | Northstar Rx |
| NDC | 16714-299-03 |
Indications and Usage
Amoxicillin is indicated for the treatment of infections caused by susceptible strains of designated bacteria, including infections of the ear, nose, and throat; genitourinary tract; skin and skin structures; and lower respiratory tract. It may also be used as part of Helicobacter pylori eradication regimens. Use only for proven or strongly suspected bacterial infections.
Dosage and Administration
Usual adult dosage ranges from 250 mg to 500 mg every 8 hours, or 500 mg to 875 mg every 12 hours, depending on the type and severity of the infection. Treatment duration varies by indication. Therapy should generally continue for at least 48 to 72 hours after symptoms resolve. Infections caused by Streptococcus pyogenes should be treated for a minimum of 10 days. Follow the prescriber's directions and the official prescribing information.
Warnings and Precautions
- Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, can occur with penicillins.
- Clostridioides difficile-associated diarrhea and colitis may develop.
- A high incidence of erythematous rash has been reported when amoxicillin is administered to patients with mononucleosis.
- Prescribing without a proven or strongly suspected bacterial infection increases the risk of drug-resistant bacteria.
Contraindications
Contraindicated in patients with a history of serious hypersensitivity reactions, such as anaphylaxis or Stevens-Johnson syndrome, to amoxicillin or other beta-lactam antibiotics, including penicillins and cephalosporins.
Adverse Reactions
The most common adverse reactions include diarrhea, rash, vomiting, and nausea.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F). Dispense in a tight, light-resistant container.
How Supplied
Amoxicillin 500 mg is supplied as ivory hard-gelatin capsules in oral-dose bottles, including a 100-count bottle. NDC: 16714-299-03.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
If you have any questions related to DSCSA compliance, transaction history, regulatory data, or quality assurance, please contact our team at compliance@dryeyerescue.com for more information.
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