Bottle Label 600 mg (71610 0601 60)
Gemfibrozil Tablet
Product Images NDC 71610-601
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Product Visual Gallery
This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 71610-601). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Aphena Pharma Solutions - Tennessee, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Additional Adv Reactions (Additional Adv Reactions)
Adv Reactions (Adverse Reactions)
This text describes the frequency in percentage of gastrointestinal reactions and adverse events experienced by subjects who were administered either Gemfibrozil or a placebo. It reports the occurrence of dyspepsia, abdominal pain, acute appendicitis, and atrial fibrillation among others, in each group. The text also lists adverse events reported by more than 1% of subjects in both groups, which include diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache.*
Aphena Pharma Solutions (TN)
Struct (Struct Gemfibrozil)
The text is a chemical formula that represents a molecule composed of carbon, hydrogen, and oxygen atoms. It is not possible to determine the name or properties of the molecule with this limited information.*
Tab 1 (Tab 1)
This describes a table depicting CHD (coronary heart disease) rates in patients based on their baseline lipids. It shows the reduction in events per 1000 patients during years 0-5 of the Helsinki Heart Study. The patients are divided into different groups based on their lipid levels, including LDL-C (>175), HDL-C (>46.4, <35), and TG (>200). The table further shows incidence of events and the difference in rates between the placebo and gemfibrozil groups. The events refer to fatal and non-fatal myocardial infarctions and sudden cardiac deaths.*
Tab 2 (Tab 2)
The table presents the Cardiac Events and All-Cause Mortality occurring during the 3.5 Year Open-Label Follow-up to the Helsinki Heart Study with six open-label groups. The groups are identified first by the original randomization (P = placebo, G = Gemfibrozil) and then by the drug taken in the follow-up period. The table also provides the number of patients in each group.*
Tab 3 (Tab 3)
The table presents data from the Helsinki Heart Study, which analyzed the effect of gemfibrozil on cardiac events, deaths from cardiac and non-cardiac causes, and all-cause mortality. The study lasted 8.5 years and compared the outcomes of patients on gemfibrozil to those on a placebo. The table shows the number of events, the hazard ratios, and 95% confidence intervals. The intention-to-treat analysis was used, neglecting open-label treatment switches and exposure to study conditions. "Cardiac events" refers to fatal and non-fatal myocardial infarctions plus sudden cardiac deaths over the 8.5 year period.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
