Amoxicillin Tablets 500MG 100/Count - Northstar

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.

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