Gemfibrozil Tablet
Product Images NDC 70518-4305

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Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemfibrozil (NDC 70518-4305). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Additional Adverse Reactions (Additional Adv Drug Reactions)

Additional Adverse Reactions (Additional Adv Drug Reactions)
This text provides a list of potential side effects and conditions associated with a medication or treatment. These include issues related to various bodily systems such as the cardiovascular (extrasystoles), gastrointestinal (cholestati jaundice, pancreatitis), Central Nervous System (dizziness, confusion), Genitourinary (impotence, decreased male fertility), and more. Additionally, it mentions laboratory findings like increased liver enzymes, potential hematological concerns (anemia, thrombocytopenia), and immunological reactions like angioedema and laryngeal edema. The text also touches on dermatological symptoms such as alopecia and dermatitis.*
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Adverse Reactions (Adv Reactions)

Adverse Reactions (Adv Reactions)
This text provides a comparison of adverse events between subjects who received Gemfibrozil and those who received a placebo. The frequency of gastrointestinal reactions, dyspepsia, abdominal pain, acute appendicitis, atrial fibrillation, diarrhea, fatigue, nausea/vomiting, eczema, rash, vertigo, constipation, and headache is presented in percentages for each group. There were some adverse events reported by more than 1% of subjects, with no significant difference between the Gemfibrozil and placebo groups.*
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Remedy_label (Remedy Label)

Remedy_label (Remedy Label)
This text provides information about Gemfibrozil tablets in a dosage of 600 mg, with a quantity of 180 tablets. It includes instructions to protect from light and humidity, a prescription-only note, NDC number, manufacturer details (Camber Pharma, Inc), storage instructions, and details of repackaging by RemedyRepack Inc. The text also suggests referring to the package insert for usage directions and mentions keeping medication out of reach of children.*
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Struct (Structure Gemfibrozil)

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Table1 (Table 1)

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Table2 (Table 2)

Table2 (Table   2)
The table presents data on cardiac events and all-cause mortality (events per 1000 patients) observed during a 3.5-year open-label follow-up to the Helsinki Heart Study. The groups involved in the study are categorized as referred to by the initial randomization (P = placebo, G = Gemfibrozil) and then by the drug taken during the follow-up (N = Attend clinic but took no drug, G = Gemfibrozil, Drop = No attendance at clinic during open-label). The data includes the number of patients in each group and the corresponding cardiac events and all-cause mortality rates.*
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Table3 (Table 3)

Table3 (Table   3)
This text provides data from the Helsinki Heart Study, detailing cardiac events, cardiac and non-cardiac deaths, and all-cause mortality over a period of 8.5 years. The study compared outcomes between patients receiving gemfibrozil and those receiving a placebo. The results show hazard ratios for different events such as cardiac events, cardiac deaths, non-cardiac deaths, and all-cause mortality. The intention-to-treat analysis was conducted on the originally randomized patients, ignoring any open-label treatment switches or exposure to study conditions. The confidence intervals for the hazard ratio comparing gemfibrozil to placebo are also provided. Overall, the study aimed to assess fatal and non-fatal myocardial infarctions along with 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.