Label: AMOXICILLIN capsule
- NDC Code(s): 51655-894-52
- Packager: Northwind Pharmaceuticals, LLC
- This is a repackaged label.
- Source NDC Code(s): 0781-2613
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 1, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension safely and effectively. See full prescribing information for AMOXICILLIN ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 Infections of the Ear, Nose, and Throat - Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of - Streptococcusspecies. (α ...
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2 DOSAGE AND ADMINISTRATION2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age - Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of ...
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3 DOSAGE FORMS AND STRENGTHSCapsules:250 mg, 500 mg. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one ...
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4 CONTRAINDICATIONSAmoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactam ...
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5 WARNINGS AND PRECAUTIONS5.1 Anaphylactic Reactions - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although ...
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6 ADVERSE REACTIONSThe following are discussed in more detail in other sections of the labeling: Anaphylactic reactions - [see Warnings and Precautions (5.1)] CDAD - [see Warnings and Precautions ...
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7 DRUG INTERACTIONS7.1 Probenecid - Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body ...
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10 OVERDOSAGEIn case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center ...
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11 DESCRIPTIONFormulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Amoxicillin is an antibacterial drug - [see Microbiology ( 12.4)]. 12.3 Pharmacokinetics - Absorption: Amoxicillin is stable in the presence of gastric ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of ...
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14 CLINICAL STUDIES14.1 - H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence - Randomized, double-blind clinical studies performed in the United States in patients with - H. pyloriand duodenal ...
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15 REFERENCESSwanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
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16 HOW SUPPLIED/STORAGE AND HANDLINGAmoxicillin Capsules, USP,for oral administration 500 mg amoxicillin as the trihydrate and are supplied as: 500 mg:yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG ...
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17 PATIENT COUNSELING INFORMATIONInformation for Patients - Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Patients should be counseled that ...
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Principal Display PanelNDC: 51655-894-52
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INGREDIENTS AND APPEARANCEProduct Information