Gabapentin Tablet
Product Images NDC 60760-987

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Gabapentin (NDC 60760-987). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by St. Mary's Medical Park Pharmacy, 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

987-90 (Gabapentin 60760 987 90)

Label for Gabapentin tablets, USP, 600 mg strength, with quantity of 90 tablets. Manufactured by Ascent Pharmaceuticals, Inc. in Central Islip, NY, and packaged by St. Mary's Medical Park Pharmacy in Oro Valley, AZ. The label includes storage instructions to keep at controlled room temperature and has various placeholder fields for lot number, expiration date, and prescription number.*

FDA Label Image

Sideeffects (Sideeffects)

This image shows a partial text panel listing potential side effects or adverse reactions, including symptoms like lack of coordination, viral infection, difficulty speaking, tremor, swelling of legs and feet, feeling tired, fever, drowsiness, nausea and vomiting, jerky movements, double vision, and unusual eye movement. The content appears to be part of a medication safety or warning section.*

FDA Label Image

Table-1 (Table1)

A detailed data table titled 'Gabapentin Dosage Based on Renal Function' showing dose adjustments according to renal function measured by creatinine clearance (mL/min). The table lists total daily dose ranges and dose regimens in mg for various creatinine clearance levels, including supplemental doses for patients on hemodialysis. Abbreviations and notes on dose reductions and maintenance dosing are included below the table.*

FDA Label Image

Table-2 (Table2)

A data table titled 'TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis.' It lists incidences of events per 1,000 patients in placebo and drug groups, relative risk, and risk difference for epilepsy, psychiatric, other, and total indications.*

FDA Label Image

Table-3 (Table3)

Table 3 showing adverse reactions in pooled placebo-controlled trials of Gabapentin versus placebo in postherpetic neuralgia. It lists percentage incidences of side effects across categories like Body as a Whole, Digestive System, Metabolic and Nutritional Disorders, Nervous System, Respiratory System, and Special Senses for Gabapentin and placebo groups.*

FDA Label Image

Table-4 (Table4)

Table showing adverse reactions in pooled placebo-controlled add-on trials in epilepsy patients aged over 12 years, comparing gabapentin (N=543) and placebo (N=378). Reactions are grouped by body systems including nervous, digestive, cardiovascular, respiratory, skin, and others, with percentages for each adverse event listed for both gabapentin and placebo groups.*

FDA Label Image

Table-5 (Table5)

A data table titled 'Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years.' It compares the percentage incidence of various adverse reactions in patients taking Gabapentin (N=119) versus Placebo (N=128) across body systems including Body As A Whole, Digestive System, Nervous System, and Respiratory System.*

FDA Label Image

Table-6 (Table6)

A table titled 'Controlled PHN Studies: Duration, Dosages, and Number of Patients' summarizing two studies. It includes study duration (8 and 7 weeks), gabapentin target doses (3600 mg/day and 1800 or 2400 mg/day), and counts of patients receiving gabapentin (113 and 223) and placebo (116 and 111) with totals provided.*

FDA Label Image

Clcr (Clcr)

An illustration of the formula for calculating creatinine clearance (CLCr), including variables for age, weight, serum creatinine, and a correction factor for female patients. The equation is displayed clearly with numeric and algebraic components.*

FDA Label Image

Figure-1 (Figure1)

A line graph depicting weekly mean pain scores over eight weeks in a clinical study comparing placebo and gabapentin 3600 mg/day. The x-axis represents weeks from baseline to week 8, and the y-axis shows mean pain scores ranging from 0 to 10. Two study phases, 4-week dose titration and 4-week fixed dose, are indicated.*

FDA Label Image

Figure-2 (Figure2)

Line graph showing weekly mean pain scores over 7 weeks in a clinical study comparing placebo, gabapentin 1800 mg/day, and gabapentin 2400 mg/day. The x-axis represents weeks, including a 3-week dose titration period and a 4-week fixed dose period. The y-axis shows the mean pain score from 0 to 10, with both gabapentin doses showing lower mean pain scores than placebo throughout the study.*

FDA Label Image

Figure-3 (Figure3)

Bar chart titled 'Proportion of Responders (patients with ≥50% reduction in pain score) at Endpoint: Controlled PHN Studies' showing results from two studies. Study 1 compares placebo (PBO) with Gabapentin 3600 mg (GBP 3600), and Study 2 compares placebo with Gabapentin 1800 mg and 2400 mg doses. The chart indicates higher responder proportions for Gabapentin groups versus placebo with statistical significance noted.*

FDA Label Image

Figure-4 (Figure4)

A scatter plot graph showing responder rate differences from placebo by Gabapentin daily dose (mg) in adjunctive therapy studies for patients aged 12 and older with partial seizures. The x-axis represents daily dose (600 to 1800 mg) and the y-axis shows difference percentage (2% to 22%). Three studies are plotted with different markers and labels (a, b, c) indicating responder rates at various doses.*

FDA Label Image

Struc (Struct)

Chemical structure of Gabapentin, showing a cyclohexane ring bonded to a side chain with an amino group (CH2NH2) and a carboxylic acid group (CH2CO2H).*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.