Guanfacine Tablet, Extended Release
Product Images NDC 16714-191

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Guanfacine (NDC 16714-191). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, 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

Guanfacine-1 mg (Image 01)

Label for Guanfacine Extended-Release Tablets, USP 1 mg, with 100 tablets per bottle. The label states the tablets should not be crushed, chewed, or broken before swallowing. Manufactured for NorthStar Rx LLC and by Ohm Laboratories Inc. This product is made in Spain.*

FDA Label Image

Guanfacine- 2 mg (Image 02)

Label for Guanfacine Extended-Release Tablets, USP 2 mg by NorthStar Rx LLC. The label indicates 100 tablets per bottle, with a warning that tablets should not be crushed, chewed, or broken before swallowing. It includes storage instructions and manufacturer information, identifying Ohm Laboratories Inc. in New Jersey as the manufacturer and NorthStar Rx LLC in Memphis, Tennessee as the labeler.*

FDA Label Image

Guanfacine- 3 mg (Image 03)

Label for Guanfacine Extended-Release Tablets, USP 3 mg, oral extended-release tablets. The package contains 100 tablets and is labeled for prescription use only. Manufactured for NorthStar Rx LLC, Memphis, TN, and by Ohm Laboratories Inc., New Brunswick, NJ. The label includes storage instructions and a warning that tablets should not be crushed, chewed, or broken before swallowing.*

FDA Label Image

Guanfacine- 4 mg (Image 04)

Label for Guanfacine Extended-Release Tablets, USP, 4 mg strength. The label states the tablets should not be crushed, chewed, or broken before swallowing. It includes manufacturer details for NorthStar Rx LLC and Ohm Laboratories Inc., mentions storage conditions, and shows a barcode. The package contains 100 tablets.*

FDA Label Image

Spl-guanfacine-northstar-figure 1 (Spl Guanfacine Northstar Figure 1)

A line graph showing plasma concentration (ng/mL) of guanfacine over time (hours) for 1 mg doses. It compares guanfacine extended-release tablets (solid line with squares) and Tenex 1 mg QD (dashed line with triangles) showing concentration changes from 0 to 24 hours.*

FDA Label Image

Spl-guanfacine-northstar-figure 2 (Spl Guanfacine Northstar Figure 2)

A fold change graph showing the impact of various substances on the exposure (measured as Cmax and AUC) of Guanfacine extended-release tablets. The graph includes CYP3A4/5 inhibitors (Ketoconazole), CYP3A4 inducers (Rifampin), and other agents such as Fluvoxamine, Elvitegravir, Oral Methylphenidate, and Lisdexamfetamine Dimesylate. Data sources vary between human data and computer simulations, with fold change and 90% confidence intervals plotted on the X-axis relative to a reference value of 1.*

FDA Label Image

Spl-guanfacine-northstar-figure 3 (Spl Guanfacine Northstar Figure 3)

A pharmacokinetic (PK) chart showing fold changes and 90% confidence intervals for Cmax and AUC of oral Methylphenidate and Lisdexamfetamine Dimesylate compared to reference values. The x-axis represents the change relative to reference, ranging from 0.0 to 2.0.*

FDA Label Image

Spl-guanfacine-northstar-figure 4 (Spl Guanfacine Northstar Figure 4)

A Kaplan-Meier plot showing treatment failure (%) over time (days) for two groups: Placebo (solid line) and SPD503 (dashed line). The graph depicts a lower rate of treatment failure over time for the SPD503 group compared to Placebo, with time ranging from 0 to over 200 days and treatment failure percentage from 0% to 100%.*

FDA Label Image

Spl-guanfacine-northstar-structure (Spl Guanfacine Northstar Structure)

Chemical structure diagram of Guanfacine hydrochloride, showing its molecular arrangement including chloro-substituted aromatic rings and imidazoline moiety.*

* 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.