Amoxicillin / Clavulanate Potassium 875 mg / 125 mg Tablets, 20 count — Aurobindo Pharma Ltd.

Amoxicillin / Clavulanate Potassium 875 mg / 125 mg Tablets, 20 Count

NDC: 65862-503-20

Product Details

Active Ingredients	Amoxicillin 875 mg (as amoxicillin trihydrate) and clavulanic acid 125 mg (as potassium salt) per tablet
Dosage Form	Film-coated, scored oral tablet
Route	Oral
Package Size	20 tablets per bottle
Manufacturer	Aurobindo Pharma Ltd.
NDC	65862-503-20

Indications and Usage

Amoxicillin and clavulanate potassium is indicated for the treatment of susceptible beta-lactamase-producing bacterial infections, including lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin-structure infections, and urinary tract infections.

Dosage and Administration

Adults and pediatric patients weighing 40 kg or more: The usual dose for the 875 mg / 125 mg tablet is one tablet every 12 hours, based on the amoxicillin component, as directed by a healthcare professional. Take at the start of a meal to reduce gastrointestinal upset.

Warnings and Precautions

• Serious hypersensitivity: Serious and potentially fatal allergic reactions, including anaphylaxis, may occur.
• Severe skin reactions: Discontinue use if a severe or progressive rash or other signs of a serious skin reaction develop.
• Clostridioides difficile-associated diarrhea: Antibiotic-associated diarrhea may range from mild to severe colitis.
• Hepatic dysfunction: Liver dysfunction and cholestatic jaundice have been reported.
• Mononucleosis: Avoid use in patients with mononucleosis due to an increased risk of rash.

Contraindications

Contraindicated in patients with a history of serious hypersensitivity reactions to penicillins or cephalosporins, or a history of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate.

Adverse Reactions

Common adverse reactions include diarrhea or loose stools, nausea, and skin rash or urticaria.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F) in a tight container. Excursions are permitted according to applicable product labeling.

How Supplied

Supplied as 20 scored, capsule-shaped tablets in a bottle.

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Professional use only.

Clinical information is summarized from FDA-approved prescribing information (Structured Product Labeling). Refer to the full prescribing information via DailyMed for complete details.

For product or compliance questions, contact compliance@dryeyerescue.com.