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Amoxicillin 500 MG Clavulanate 125 MG Oral Tablet

1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: Amoxicillin and clavulanate potassium tablets are combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections ( 1.1 ) Acute bacterial otitis media ( 1.2 ) Sinusitis ( 1.3 ) Skin and skin structure infections ( 1.4 ) Urinary tract infections ( 1.5 ) 1.1 Lower Respiratory Tract Infections – caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . 1.2 Acute Bacterial Otitis Media – caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis . 1.3 Sinusitis - caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis . 1.4 Skin and Skin Structure Infections – caused by beta-lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. 1.5 Urinary Tract Infections – caused by beta-lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species. 1.6 Limitations of Use – When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.

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2 years ago OVAL WHITE I06 Amoxicillin 500 MG  Clavulanate 125 MG Oral Tablet

OVAL WHITE I06

2 years ago OVAL WHITE I06 Amoxicillin 500 MG  Clavulanate 125 MG Oral Tablet

I06 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

AMOXICILLIN AND CLAVULANATE POTASSIUM Tablets USP are supplied as follows:

AMOXICILLIN AND CLAVULANATE POTASSIUM tablets USP, 250 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets, debossed with “I 05” on one side and plain on the other side. Each tablet contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows. Bottles of 30 NDC 42571-160-30 Bottles of 100 NDC 42571-160-01 Carton of 100 (10x10 Unit-dose) NDC 42571-160-11

AMOXICILLIN AND CLAVULANATE POTASSIUM tablets USP, 500 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 06” on one side and plain on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows. Bottles of 20 NDC 42571-161-42 Bottles of 100 NDC 42571-161-01 Carton of 100 (10x10 Unit-dose) NDC 42571-161-11

AMOXICILLIN AND CLAVULANATE POTASSIUM tablets USP, 875 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side score line on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows. Bottles of 20 NDC 42571-162-42 Bottles of 100 NDC 42571-162-01 Carton of 40 (4x10 Unit-dose) NDC 42571-162-44 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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