Clonidine Tablet, Extended Release
Product Images NDC 50742-247

13 FDA label images from Ingenus Pharmaceuticals, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Clonidine (NDC 50742-247). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, 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

Image-02 (Image 01)

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A table presenting common adverse reactions reported by patients in a fixed-dose monotherapy trial for Clonidine hydrochloride extended-release tablets. It compares percentages of patients experiencing various psychiatric, nervous system, gastrointestinal, general, cardiac disorders, investigations, and metabolism and nutrition disorders across different dosages (0.2 mg/day, 0.4 mg/day) and placebo groups.*
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A data table titled 'Common Adverse Reactions in the Fixed-Dose Monotherapy Trial - Taper Period' comparing the percentage of patients reporting specific adverse events. The table includes data for clonidine hydrochloride extended-release tablets at 0.2 mg/day and 0.4 mg/day doses, as well as a placebo group, across various adverse reaction terms such as abdominal pain upper, headache, gastrointestinal viral, somnolence, heart rate increased, and otitis media acute.*
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A table titled "Common Adverse Reactions in the Flexible-Dose Adjunctive to Stimulant Therapy Trial - Treatment Period (Study 2)" comparing percentages of patients reporting various adverse events. It contrasts Clonidine hydrochloride extended-release tablets plus stimulant therapy (N=102) with placebo plus stimulant therapy (N=96), listing disorders such as psychiatric, general, nervous system, gastrointestinal, respiratory, metabolism and nutrition, and cardiac disorders along with specific symptoms and their reported percentages.*
FDA Label Image

Image-05 (Image 04)

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Chemical structure of clonidine hydrochloride, showing its molecular formula C9H9Cl2N3·HCl and molecular weight 266.56. The structure includes a dichlorobenzene ring connected to an imidazoline ring with hydrochloride salt notation.*
FDA Label Image

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Table presenting pharmacokinetic parameters of clonidine in healthy adult volunteers, comparing immediate-release tablets (fasted) with extended-release tablets under fed and fasted conditions. Parameters include Cmax, AUCinf, hTmax, and T1/2 with mean values and standard deviations for each group.*
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Image-07 (Image 06)

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A line chart showing mean clonidine concentration over time after a single dose administration. The x-axis represents time in hours up to 48 hours, and the y-axis represents mean concentration in pg/mL. Three profiles are compared: clonidine hydrochloride extended-release tablets under fasting, extended-release tablets fed, and immediate-release tablets fasting, showing differences in concentration-time profiles.*
FDA Label Image

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A data table titled 'Table 8 Short-Term Trials' summarizing clinical trials for clonidine extended-release tablets. It shows study numbers, treatment groups, mean baseline ADHD rating scale scores, least-squares mean changes from baseline, and placebo-subtracted differences with confidence intervals. The table includes comparisons of different clonidine doses and combinations with psychostimulants versus placebo.*
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Table titled 'Treatment Failure: Double-Blind Full Analysis Set (Study 3)' comparing treatment failure data between clonidine hydrochloride extended-release tablets and placebo groups. It includes number of subjects, treatment failure counts and percentages, and reasons for failure such as clinical criteria, lack of efficacy, withdrawal of consent, and other early terminations with associated percentages.*
FDA Label Image

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A Kaplan-Meier curve chart showing the cumulative proportion of patients experiencing treatment failure over time in days. It compares Clonidine HCl extended-release tablets versus placebo, with separate lines for each group and markers indicating censored data points.*
FDA Label Image

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FDA Label Image

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Label for Clonidine HCl Extended-Release Tablets, 0.1 mg strength, oral tablets in extended-release form. The label shows a package of 60 tablets manufactured by Ingenus Pharmaceuticals, LLC. It includes dosing instructions, storage conditions, barcode, and warnings. The label prominently displays the product name, strength, package quantity, NDC 50742-247, and manufacturer details.*
FDA Label Image

Image-14 (Image 13)

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A table presenting common adverse reactions reported in a flexible-dose adjunct to stimulant therapy trial during the taper period (weeks 6-8). It compares the percentage of patients reporting events such as nasal congestion, headache, irritability, throat pain, viral gastroenteritis, and rash between Clonidine hydrochloride extended-release tablets plus stimulant therapy (N=102) and placebo plus stimulant therapy (N=96).*

* 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.