Guanfacine
Product Images NDC 42291-324

14 FDA label images from Avkare · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Guanfacine (NDC 42291-324). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

1 (Table 1)

1 (Table 1)
A data table titled 'Recommended Target Dose Range for Therapy with Guanfacine Extended-Release' showing weight categories in kilograms alongside corresponding target dose ranges in mg per day. The table lists six weight ranges from 25 to over 91 kg with increasing dose ranges from 2-3 mg/day up to 5-7 mg/day.*
FDA Label Image

The Following Chemical Structure Of Guanfacine Hydrochloride, Usp Is A White To Off-white Crystalline Powder, Sparingly Soluble In Water (approximately 1 mg/ml) And Alcohol And Slightly Soluble In Ace (Guanfacine 1)

The Following Chemical Structure Of Guanfacine Hydrochloride, Usp Is A White To Off-white Crystalline Powder, Sparingly Soluble In Water (approximately 1 mg/ml) And Alcohol And Slightly Soluble In Ace (Guanfacine 1)
Chemical structure diagram of guanfacine hydrochloride showing its molecular framework with chlorine atoms indicated, consistent with the active ingredient guanfacine from the provided product data by AvKARE.*
FDA Label Image

Correct-figure (Guanfacine 2)

Correct-figure (Guanfacine 2)
A line graph comparing guanfacine plasma concentration (ng/mL) over 24 hours for two formulations: Guanfacine Extended-Release 1 mg QD and Immediate-Release Guanfacine 1 mg QD. The graph shows plasma concentration on the y-axis and time in hours on the x-axis.*
FDA Label Image

Figure 2: Effect Of Other Drugs On The Pharmacokinetics (pk) Of Guanfacine Extended-release (Guanfacine 3)

Figure 2: Effect Of Other Drugs On The Pharmacokinetics (pk) Of Guanfacine Extended-release (Guanfacine 3)
A pharmacokinetic interaction graph showing fold changes and 90% confidence intervals in Cmax and AUC for guanfacine when coadministered with various CYP3A4/5 inhibitors and inducers including Ketoconazole, Fluconazole, Rifampin, Efavirenz, Oral Methylphenidate, and Lisdexamfetamine Dimesylate, comparing changes relative to reference.*
FDA Label Image

Figure 3: Effect Of Guanfacine Extended-release On The Pharmacokinetics (pk) Of Other Drugs (Guanfacine 4)

Figure 3: Effect Of Guanfacine Extended-release On The Pharmacokinetics (pk) Of Other Drugs (Guanfacine 4)
A forest plot illustrating the pharmacokinetic interaction effects of oral methylphenidate and lisdexamfetamine dimesylate on guanfacine. It shows fold change and 90% confidence intervals for Cmax and AUC parameters, with a reference line at 1.0 indicating no change relative to reference values.*
FDA Label Image

1 (Figure 4)

1 (Figure 4)
Kaplan-Meier curve illustrating the proportion of children and adolescents aged 6 to 17 experiencing treatment failure over time up to 203 days. The graph compares treatment failure percentages between placebo and SP D503 groups, showing higher failure rates for the placebo group throughout the study period.*
FDA Label Image

Round Tablet Debossed (Guanfacine 5)

Round Tablet Debossed (Guanfacine 5)
Packaging label for guanfacine tablets from AvKARE. The label includes brand and generic names, packaging details, and dosage guidance, primarily in English and Spanish. The bottle container is amber with a white cap and a white label featuring various safety, storage, and regulatory information.*
FDA Label Image

Round Tablet Debossed (Guanfacine 6)

Round Tablet Debossed (Guanfacine 6)
Packaging label of guanfacine tablets by AvKARE. The white rectangular label includes the drug name guanfacine and contains printed information, barcodes, and a warning statement. The label is sterile and designed for prescription medication.*
FDA Label Image

Round Tablet Debossed (Guanfacine 7)

Round Tablet Debossed (Guanfacine 7)
The image shows a rectangular carton for guanfacine tablets. The label includes the proprietary name "guanfacine" prominently. The labeler, AvKARE, is also displayed. The packaging features a predominantly blue and yellow color scheme with text blocks, including dosing and regulatory information boxes, but specific strength or dosage form details are not visible in the image.*
FDA Label Image

Round Tablet Debossed (Guanfacine 8)

Round Tablet Debossed (Guanfacine 8)
The image shows a prescription pill bottle label for guanfacine by AvKARE. The label includes standard drug information sections such as warnings, directions, storage information, and manufacturer details. It is a typical pharmacy bottle label with clear black text on a white background and a barcode at the bottom.*
FDA Label Image

1 (324 01)

1 (324 01)
Label for Guanfacine Extended-Release Tablets 1 mg by AvKARE. The label includes the NDC 42291-324-01, instructions that tablets should not be crushed, chewed, or broken, and that the package contains 100 tablets. Additional information includes pharmacy dispensing instructions, storage conditions, and safety warnings.*
FDA Label Image

1 (325 01)

1 (325 01)
The packaging label for AvKARE Guanfacine Extended-Release Tablets, 2 mg strength, containing 100 tablets. The label includes the brand name, dosage form, strength, quantity, and cautions about not crushing, chewing, or breaking tablets. It is marked as Rx only and features the NDC code 42291-325-01.*
FDA Label Image

1 (326 01)

1 (326 01)
Label for Guanfacine Extended-Release Tablets, 3 mg strength, from AvKARE. The label indicates 100 tablets per package and states that tablets should not be crushed, chewed, or broken before swallowing. It includes patient information and usage instructions, along with storage conditions and manufacturing details.*
FDA Label Image

1 (327 01)

1 (327 01)
Label for AvKARE guanfacine extended-release tablets. Each tablet contains 4 mg of guanfacine. The package contains 100 tablets. The label includes warnings not to crush, chew, or break the tablets before swallowing, pharmacist dispensing instructions, and storage conditions. The label also displays the NDC 42291-327-01 and states Rx only.*

* 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.