Gemfibrozil Tablet
Product Images NDC 72865-186

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 72865-186). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

600 mg- 500s (600 mg 500 Count)

600 mg- 500s (600 mg 500 Count)
This is a description for a medication called XLcare, specifically a type of tablet containing 600mg of gemfibrozil. The tablets come in a quantity of 500 and are only available with a prescription. The text provides instructions for storing the medication (in a controlled room temperature protected from light and humidity) and lists the manufacturer and distributor of the tablets. It also advises the reader to refer to the package insert for complete prescribing information.*
FDA Label Image

Additional Adv Reactions (Additional Adv Reactions)

Additional Adv Reactions (Additional Adv Reactions)
This text is describing potential side effects of a medication, including impact to various body systems such as the gastrointestinal, musculoskeletal, and central nervous systems, as well as clinical laboratory readings. The causal relationship of these symptoms to the medication is not established.*
FDA Label Image

Adv Reactions (Adverse Reactions)

Adv Reactions (Adverse Reactions)
This is a report on the adverse effects of Gemfibrozil compared to Placebo on a group of participants. The report displays the frequency of gastrointestinal reactions such as dyspepsia, abdominal pain, acute appendicitis, and Atrial fibrillation experienced by the participants under each treatment. In addition to the above gastrointestinal reactions, other Adverse events including diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache were reported by more than 1% of subjects but with no significant difference between groups.*
FDA Label Image

Struct (Struct Gemfibrozil)

Struct (Struct Gemfibrozil)
The text appears to be a chemical formula, possibly representing a molecule with carbon, hydrogen, and oxygen atoms. However, without more information or context it is impossible to determine the specific compound being represented.*
FDA Label Image

Tab 1 (Tab 1)

Tab 1 (Tab  1)
The text describes a table presenting the reduction in CHD rates (events per 1000 patients) by baseline lipids in the Helsinki Heart Study from years 0-5. The table includes various lipid values at baseline and the incidence of events (fatal and nonfatal myocardial infarctions plus sudden cardiac deaths) in both the placebo and gemfibrozil groups. The difference in rates between the two groups is also included.*
FDA Label Image

Tab 2 (Tab 2)

Tab 2 (Tab  2)
This is a table showing the number of cardiac events and all-cause mortality per 1000 patients during the 3.5 years of open-label follow-up to the Helsinki Heart study. The six open-label groups are identified by a combination of original randomization (P = placebo, G = Gemfibrozil) and drug taken during the follow-up (N = Attend clinic but took no drug, G = Gemfibrozil, Drop = No attendance at clinic during open-label). The table lists the number of patients in each group (N) and the respective numbers of cardiac events and all-cause mortality.*
FDA Label Image

Tab 3 (Tab 3)

Tab 3 (Tab  3)
The table provides information on Cardiac Events, Cardiac Deaths, Non-Cardiac Deaths, and All-Cause Mortality in the Helsinki Heart Study over a period of 8.5 years. The study compares the effects of Gemfibrozil and Placebo, using hazard ratios to compare the groups originally randomized to the drugs. The intention-to-treat analysis was done on the patients originally randomized to the study drugs, excluding open-label treatment switches and exposure to study conditions. The group originally randomized to Gemfibrozil had a lower hazard ratio for Cardiac Events, but no significant difference for Cardiac Deaths, and higher hazard ratios for Non-Cardiac Deaths and All-Cause Mortality compared to the group originally randomized to Placebo.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.