Guanfacine Tablet, Extended Release
Product Images NDC 71205-945

10 FDA label images from Proficient Rx Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Guanfacine (NDC 71205-945). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

71205-944-30 (Bottle Label 1 mg)

71205-944-30 (Bottle Label 1 mg)
Label for Guanfacine 1 mg extended-release tablets, packaged in a quantity of 30. The label specifies that each extended-release tablet contains 1.14 mg of guanfacine hydrochloride equivalent to 1 mg guanfacine. The labeler is Proficient Rx LP, with manufacturing by TWI Pharmaceuticals, Inc. Dosage form is oral extended-release tablet.*
FDA Label Image

71205-945-30 (Bottle Label 2 mg)

71205-945-30 (Bottle Label 2 mg)
Label for Guanfacine 2 mg extended-release tablets, with a count of 30 tablets. The label shows active ingredient content as 2 mg guanfacine per tablet, manufactured by TWi Pharmaceuticals, Inc. The label includes handling instructions and storage conditions, and is packaged by Proficient Rx LP, Thousand Oaks, CA.*
FDA Label Image

71205-946-30 (Bottle Label 3 mg)

71205-946-30 (Bottle Label 3 mg)
Label for Guanfacine 3 mg extended-release oral tablets by Proficient Rx LP. The package contains 30 tablets, each with 3.42 mg guanfacine hydrochloride equivalent to 3 mg guanfacine. Tablets are blue, round, and debossed with "A536" and "3 mg." Manufactured by TWi Pharmaceuticals, Inc., Taiwan, with storage instructions at 20°-25°C.*
FDA Label Image

71205-947-30 (Bottle Label 4 mg)

71205-947-30 (Bottle Label 4 mg)
Label for Guanfacine Extended-Release 4 mg ER oral tablets by Proficient Rx LP. The package contains 30 tablets. Each blue, caplet-shaped tablet is debossed with "A538" on one side and "4 mg" on the other. The label advises not to crush, chew, or break tablets before swallowing and includes storage instructions and manufacturer information.*
FDA Label Image

Figure-1.jpg (Figure 1)

Figure-1.jpg (Figure 1)
A pharmacokinetic line graph comparing Guanfacine Extended-Release Tablets 1 mg QD and Tenex 1 mg QD. The x-axis represents time in hours (0 to 24), and the y-axis shows Guanfacine plasma concentration (ng/mL). Guanfacine Extended-Release shows a more gradual increase and sustained concentration, while Tenex peaks earlier and declines more rapidly.*
FDA Label Image

Figure-2.jpg (Figure 2)

Figure-2.jpg (Figure 2)
A pharmacokinetic chart showing fold change and 90% confidence intervals for Cmax and AUC values of Guanfacine when co-administered with various CYP3A4/5 inhibitors and inducers, including Ketoconazole, Fluconazole, Rifampin, Efavirenz, Oral Methylphenidate, and Lisdexamfetamine Dimesylate. The x-axis represents fold change relative to reference, with data points and error bars plotted for each drug effect.*
FDA Label Image

Figure-3.jpg (Figure 3)

Figure-3.jpg (Figure 3)
A chart depicting fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC of interacting drugs Oral Methylphenidate and Lisdexamfetamine Dimesylate. The x-axis represents change relative to reference, ranging from 0.0 to 2.0, with markers around 1.0 indicating no significant change.*
FDA Label Image

Figure-4.jpg (Figure 4)

Figure-4.jpg (Figure 4)
A line graph showing time to treatment failure in days on the x-axis and treatment failure percentage on the y-axis. The graph compares two groups: Placebo (solid line) and SPD003 (dashed line), illustrating their respective rates of treatment failure over approximately 200 days.*
FDA Label Image

Figure-5 (Figure 5)

FDA Label Image

Molecular-structure.jpg (Molecular Structure)

Molecular-structure.jpg (Molecular Structure)
Chemical structure diagram of guanfacine hydrochloride, showing the molecular arrangement including two chlorine atoms, an amide group, and a guanidine moiety associated with the hydrochloride salt form.*

* 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.