Amoxicillin / Clavulanate Potassium 875 mg / 125 mg Tablets, 20 count — Aurobindo Pharma Ltd.
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Visit Retail SiteAmoxicillin / 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.
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.
- NDC
- 65862-503-20
- Manufacturer
- Aurobindo Pharma Ltd.
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