Serialized Bag Labeling (1514 1 Serialized Package Label)
Ondansetron Tablet, Orally Disintegrating
Product Images NDC 51662-1514
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Product Visual Gallery
This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1514). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Blister Pack Labeling (51662 1514 Blister Pack Labeling)
57237 077 10 Ondansetron 2 Pack Hf Label Image
Adverse 1 (Adverse 1)
This table shows the most common adverse reactions in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens. The adverse reactions are compared between ondansetron orally disintegrating tablets (8 mg twice daily) and a placebo group. Headache, malaise/fatigue, constipation, and diarrhea are reported in greater than or equal to 5% of patients treated with ondansetron orally disintegrating tablets and at a rate that exceeded placebo.*
Adverse 2 (Adverse 2)
This is a table showing the most common adverse reactions in adults who took Ondansetron Orally Disintegrating Tablets for the Prevention of Postoperative Nausea and Vomiting, compared to placebo. The adverse reactions listed are headache, hypoxia, pyrexia, dizziness, gynecological disorder, anxiety/agitation, urinary retention, and pruritus. All adverse reactions occurred in at least 5% of patients treated with ondansetron orally disintegrating tablets and had a higher rate than the placebo group.*
Clinical P (Clinical P)
The text provides pharmacokinetic data for male and female healthy subjects who received a single dose of Ondansetron 8 mg or 24 mg. The data includes the mean peak plasma concentration, time of peak, mean plasma concentration, elimination half-life, systemic clearance, and absolute bioavailability. The data is presented in tabular form divided into two tables based on the dose given.*
Clinical S 1 (Clinical S 1)
This is a table presenting the treatment response of patients receiving moderately emetogenic chemotherapy containing cyclophosphamide-based regimen with doxorubicin. The table compares the response to ondansetron orally disintegrating tablets versus a placebo for emetic episodes. The results include the number and percentage of patients experiencing different frequencies of emetic episodes along with their corresponding p-values. The table also shows the median number of emetic episodes and the median time to first emetic episode. In some cases where at least 50% of patients did not experience emetic episodes, the median is undefined.*
Clinical S 2 (Clinical S 2)
This table presents the treatment response to Ondansetron Tablets in patients with emetic episodes. The study compared the response between those administered with the tablet twice a day and with the tablet three times a day. The response was measured in terms of the number of emetic episodes, the median time to first episode, and the median nausea score using a visual analog scale. It is noteworthy that in some cases, the median is undefined due to the absence of episodes.*
Dosage (Dosage And Administration)
Table 1 provides the recommended dosage regimen for the prevention of nausea and vomiting in adults undergoing highly emetogenic cancer chemotherapy, moderately emetogenic cancer chemotherapy, radiotherapy, and postoperative procedures. Table 2 outlines the recommended dosage regimen for pediatric patients between 4 to 17 years of age undergoing moderately emetogenic chemotherapy. Dosages and time of administration for each indication and age group are specified.*
Structure (Structure)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
