Tamsulosin Hydrochloride Capsule
Product Images NDC 71610-835

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tamsulosin Hydrochloride (NDC 71610-835). 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.

FDA Label Image

Label (71610 0835 30)

Label for Tamsulosin Hydrochloride USP 0.4 mg capsules shows a package containing 30 capsules. The label includes storage instructions to keep between 20-25 degrees Celsius, dispensing guidance, and safety warnings to keep out of reach of children. The manufacturer is Aurobindo Pharma Limited, with repackaging by Aphena Pharma Solutions - Tennessee, LLC.*

FDA Label Image

Aphena (Aphena)

FDA Label Image

Figure (Tamsulosin Fig1)

A line graph depicting mean plasma concentrations of Tamsulosin Hydrochloride (0.4 mg capsules) over 36 hours following a single dose under fasted and fed conditions. The y-axis represents plasma concentration (ng/mL) ranging from 0 to 25, and the x-axis shows time in hours from 0 to 36. Two curves are shown: a dashed line for fasted state with a higher peak around 4 hours, and a solid line for fed state with lower peak concentrations.*

FDA Label Image

Figure (Tamsulosin Fig2)

A line graph titled 'Mean Change from Baseline in Total AUA Symptom Score (0 to 35) Study 1' depicting mean symptom score changes over a 13-week treatment duration. It compares three treatments: 0.8 mg (circle markers), 0.4 mg (triangle markers), and placebo (square markers). The y-axis shows mean change values from 0 to -11, and the x-axis shows weeks from baseline (B) to 13 and LOCF. The graph shows greater symptom score reductions for 0.8 mg and 0.4 mg doses compared to placebo.*

FDA Label Image

Figure (Tamsulosin Fig3)

A line graph titled 'Mean Change from Baseline in Total AUA Symptom Score (0 to 35) Study 2' illustrating the mean change over weeks of treatment up to 13 weeks. The plot compares three groups: 0.8 mg dose, 0.4 mg dose, and placebo, showing a greater reduction in symptom score over time for the active treatment groups compared to placebo.*

FDA Label Image

Figure (Tamsulosin Fig4)

A line graph titled 'Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 1' showing mean change in urine flow over treatment duration in weeks. The graph compares treatments of 0.8 mg, 0.4 mg Tamsulosin Hydrochloride, and placebo. Mean change on the y-axis ranges from 0 to 3 mL/sec, with data points over 0 to 13 weeks on the x-axis.*

FDA Label Image

Figure (Tamsulosin Fig5)

A line graph titled 'Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 2' shows mean change in urine flow rate over treatment duration in weeks. It compares three curves representing 0.8 mg dose, 0.4 mg dose, and placebo groups, charting their mean flow rate changes from week 0 to 13 and LOCF (last observation carried forward).*

FDA Label Image

Chemical Structure (Tamsulosin Str)

Chemical structure of Tamsulosin Hydrochloride showing its molecular components including aromatic rings, functional groups, and associated hydrochloride.*

* 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.