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

NDC: 65862-503-20 Amoxicillin / Clavulanate Potassium 875 mg / 125 mg Tablets, 20 count — Aurobindo Pharma Ltd. Active ingredients Amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium salt) per tablet Dosage form Film-coated, scored oral tablet Route Oral Size 20 tablets per bottle Manufacturer Aurobindo Pharma Ltd. NDC 65862-503-20 Indications and Usage Treatment of 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: one 875 mg tablet every 12 hours (dosed on the amoxicillin component). Take at the start of a meal to reduce gastrointestinal upset. Warnings and Precautions Serious hypersensitivity and anaphylactic reactions Severe cutaneous adverse reactions; discontinue if rash progresses Clostridioides difficile-associated diarrhea Hepatic dysfunction and cholestatic jaundice; avoid use in mononucleosis Contraindications History of a serious hypersensitivity reaction to a penicillin or cephalosporin, or prior cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate. Adverse Reactions Most commonly 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. How Supplied Supplied as 20 scored, capsule-shaped tablets in a bottle. 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.