Guanfacine Tablet, Extended Release
Product Images NDC 0228-2850

13 FDA label images from Actavis Pharma, Inc. · 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 Guanfacine (NDC 0228-2850). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actavis Pharma, Inc., 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

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 Acetone. The Only Organic Solvent In Which It Has Relatively High Solubility Is Methanol (greater Than 30 mg/ml). Each Tablet Contains Guanfacine Hydrochloride, Usp Equivalent To 1 mg, 2 mg, 3 mg, Or 4 mg Of Guanfacine Base. (Image 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 Acetone. The Only Organic Solvent In Which It Has Relatively High Solubility Is Methanol (greater Than 30 mg/ml). Each Tablet Contains Guanfacine Hydrochloride, Usp Equivalent To 1 mg, 2 mg, 3 mg, Or 4 mg Of Guanfacine Base. (Image 1)
Chemical structure of guanfacine hydrochloride, showing a dichlorinated aromatic ring connected to an amide-linked guanidine functional group.*
FDA Label Image

1 (Image 10)

1 (Image 10)
Guanfacine Extended-Release Tablets 1 mg oral dosage form label by Actavis Pharma, Inc. 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, manufacturer and distributor details, and a barcode with NDC 0228-2850-11.*
FDA Label Image

2 (Image 11)

2 (Image 11)
Guanfacine 2 mg extended-release tablets labeling for oral use by Actavis Pharma, Inc. The label states tablets should not be crushed, chewed, or broken before swallowing. The package contains 100 tablets with Rx only. Additional information includes storage instructions and manufacturer details from Actavis Elizabeth LLC, Elizabeth, NJ, USA.*
FDA Label Image

3 (Image 12)

3 (Image 12)
Label for Guanfacine 3 mg extended-release oral tablets by Actavis Pharma, Inc. The label warns that tablets should not be crushed, chewed, or broken before swallowing. It indicates a package of 100 tablets and provides storage instructions and manufacturer details.*
FDA Label Image

4 (Image 13)

4 (Image 13)
Label for guanfacine extended-release tablets, 4 mg strength. The label shows the product name, dosage form, and strength prominently, specifying 100 tablets per container. It states the tablets should not be crushed, chewed, or broken before swallowing. The label lists Actavis Pharma, Inc. as the distributor and provides storage instructions and lot/expiration details along with a barcode.*
FDA Label Image

Correct-figure (Image 2)

Correct-figure (Image 2)
A line graph showing guanfacine plasma concentration (ng/mL) over 24 hours comparing guanfacine extended-release 1 mg once daily (QD) with immediate-release guanfacine 1 mg QD. The extended-release formulation exhibits a gradual increase and sustained concentration, while the immediate-release peaks sharply around 2-4 hours then declines.*
FDA Label Image

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

Figure 2: Effect Of Other Drugs On The Pharmacokinetics (pk) Of Guanfacine Extended-release (Image 3)
A chart showing fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC of guanfacine tablets extended-release under the influence of various substances. The chart compares changes due to CYP3A4/5 inhibitors (ketoconazole, fluconazole), CYP3A4 inducers (rifampin, efavirenz), oral methylphenidate, and lisdexamfetamine dimesylate relative to a reference value of 1.*
FDA Label Image

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

Figure 3: Effect Of Guanfacine Extended-release On The Pharmacokinetics (pk) Of Other Drugs (Image 4)
A forest plot chart showing the fold change and 90% confidence interval in pharmacokinetic parameters Cmax and AUC for oral methylphenidate and lisdexamfetamine dimesylate relative to a reference. The x-axis represents change relative to reference from 0.0 to 2.0, with data points for each drug and parameter plotted near 1.0, indicating no significant change.*
FDA Label Image

Figure 4 (Image 5)

Figure 4 (Image 5)
A line graph depicting treatment failure over time in days for two groups: Placebo and SPD503. The x-axis represents Time to Treatment Failure (Days) ranging from 0 to 203, and the y-axis shows Treatment Failure (%) from 0 to 100. The graph compares the cumulative percentage of treatment failure between the placebo group (solid line) and SPD503 group (dashed line) over the study duration.*
FDA Label Image

Round Tablet Debossed (Image 6)

Round Tablet Debossed (Image 6)
The image shows the carton packaging for guanfacine extended-release tablets by Actavis Pharma, Inc. It displays the product name guanfacine along with strengths of 1 mg, 2 mg, 3 mg, and 4 mg. The dosage form is indicated as extended-release tablets for oral administration. The label highlights the prescription-only status and includes standard warning and storage information.*
FDA Label Image

Round Tablet Debossed (Image 7)

Round Tablet Debossed (Image 7)
The image shows the packaging label of guanfacine extended-release tablets by Actavis Pharma, Inc. It lists four available strengths: 1 mg, 2 mg, 3 mg, and 4 mg. The product is intended for oral administration as prescription medication. The label emphasizes the extended-release tablet formulation.*
FDA Label Image

Round Tablet Debossed (Image 8)

Round Tablet Debossed (Image 8)
The image shows a carton box of guanfacine extended release tablets by Actavis Pharma, Inc. The package displays four strength options: 1 mg, 2 mg, 3 mg, and 4 mg per tablet. The form is oral tablets designed for extended release, indicated on the front of the packaging.*
FDA Label Image

Round Tablet Debossed (Image 9)

Round Tablet Debossed (Image 9)
Guanfacine extended release tablets packaging label from Actavis Pharma, Inc. The label displays each tablet strength available in this set: 1 mg, 2 mg, 3 mg, and 4 mg. The dosage form is oral tablets. The label identifies guanfacine as the active ingredient for human prescription use.*

* 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.