Label: AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

  • NDC Code(s): 16714-294-01, 16714-294-02, 16714-294-03
  • Packager: NorthStar Rx LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 3, 2025

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, safely and effectively. See full prescribing information for AMOXICILLIN ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: Recurrent or ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: 600 mg/42.9 mg per 5 mL: White to off-white, strawberry-flavored powder for oral suspension (each 5 mL of reconstituted ...
  • 4 CONTRAINDICATIONS
    4.1 Serious Hypersensitivity Reactions - Amoxicillin and clavulanate potassium for oral suspension are contraindicated in patients with a history of serious hypersensitivity reactions (e.g. ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Allergic Reactions, including Anaphylaxis - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in labeling: Anaphylactic reactions [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions ...
  • 7 DRUG INTERACTIONS
    7.1 Probenecid - Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium for oral suspension may result in increased and ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during ...
  • 10 OVERDOSAGE
    Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been ...
  • 11 DESCRIPTION
    Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Amoxicillin and clavulanate potassium for oral suspension is an antibacterial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - The pharmacokinetics of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin and clavulanate (4:1 ratio ...
  • 14 CLINICAL STUDIES
    Two clinical studies were conducted in pediatric patients with acute otitis media. A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of amoxicillin and ...
  • 15 REFERENCES
    1. Swanson-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.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: 600 mg/42.9 mg per 5 mL: White to off-white, strawberry-flavored powder for oral suspension. Following ...
  • 17 PATIENT COUNSELING INFORMATION
    Administration Instructions - Inform patients to take amoxicillin and clavulanate potassium for oral suspension every 12 hours with a meal or snack to reduce the possibility of gastrointestinal ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/42.9 mg* per 5 mL (75 mL Bottle)
    Rx only - NDC 16714-294-01 - Amoxicillin and - Clavulanate Potassium - for Oral Suspension, USP - 600 mg/42.9 mg* per 5 mL - 75 mL when reconstituted - NORTHSTAR®
  • INGREDIENTS AND APPEARANCE
    Product Information