Label: AMOXICILLIN tablet, film coated
- NDC Code(s): 63629-4777-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57237-029
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 25, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEAdults and Pediatric Patients - Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY ...
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2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions - To minimize the potential for gastrointestinal intolerance, amoxicillin tablets should be taken at the start of a meal. 2.2 Dosage for Adults and ...
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3 DOSAGE FORMS AND STRENGTHS500 mg Tablets are pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. 875 mg Tablets are pink colored, capsule shaped, film coated ...
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4 CONTRAINDICATIONSAmoxicillin tablets are contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin tablets or to other ...
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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)] Severe Cutaneous Adverse Reactions [see Warnings and ...
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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 amoxicillin ...
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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 amoxicillin, 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 DESCRIPTIONAmoxicillin tablets, USP are a semisynthetic antibacterial (amoxicillin), 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 acid and is ...
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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. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence - Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer ...
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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 Tablets, USP contains 875 mg amoxicillin as the trihydrate. Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7 ...
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17 PATIENT COUNSELING INFORMATIONAdministration Instructions - Advise patients that amoxicillin tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Allergic Reactions - Counsel patients ...
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PRINCIPAL DISPLAY PANELAmoxicillin 875mg Tablet #14
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INGREDIENTS AND APPEARANCEProduct Information