Lisdexamfetamine Dimesylate Tablet, Chewable
Product Images NDC 0406-5129

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0406-5129). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Specgx 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

Chemical Structure (Lisdexamfetamine Chewable Tabs 1)

Chemical structure of lisdexamfetamine dimesylate, showing the molecular arrangement including a phenyl group, amide linkage, and dimesylate counterions.*

FDA Label Image

10 mg Label (Lisdexamfetamine Chewable Tabs 10)

Lisdexamfetamine Dimesylate 10 mg chewable tablets label from SpecGx LLC. The label indicates 100 tablets per container, with instructions to chew tablets completely before swallowing and to dispense the medication guide separately. Storage instructions and manufacturer address in Webster Groves, MO are included.*

FDA Label Image

20 mg Label (Lisdexamfetamine Chewable Tabs 11)

Lisdexamfetamine Dimesylate 20 mg chewable tablets label. The label indicates pharmacist instructions to dispense the medication guide to patients and advises to chew tablets completely. It includes dosage information, storage instructions, and manufacturer details (SpecGx LLC, Webster Groves, MO). The strength and form (20 mg chewable tablet) are clearly noted, along with a barcode and a tablet imprint image.*

FDA Label Image

30 mg Label (Lisdexamfetamine Chewable Tabs 12)

Label for Lisdexamfetamine Dimesylate 30 mg chewable tablets by SpecGx LLC. The label includes medication instructions to chew tablets completely and not swallow whole, pharmacy guidance, storage conditions, dosage note, and a barcode. The bottle contains 100 chewable tablets.*

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Lisdexamphetamine 40 mg Tablet (Lisdexamfetamine Chewable Tabs 13)

Label for Lisdexamfetamine Dimesylate 40 mg chewable tablets. The label displays the product name, dosage strength (40 mg), and dosage form (chewable tablets). It includes usage instructions urging patients to chew tablets completely and not swallow whole. The label notes that it is manufactured by SpecGx LLC and provides storage temperature guidelines, a barcode, and a link for the medication guide. The label also shows it is for prescription use only and is branded by Mallinckrodt.*

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Lisdexamphetamine 50 mg Tablet (Lisdexamfetamine Chewable Tabs 14)

Label for Lisdexamfetamine Dimesylate 50 mg chewable tablets, containing 100 tablets per package. The label shows a white, square-shaped tablet with '50' imprinted. It includes storage instructions, a mention to see the medication guide, and states the product is manufactured by SpecGx LLC. The label also displays the NDC 0406-5128-01 and is marked Rx only.*

FDA Label Image

Lisdexamphetamine 60 mg Tablet (Lisdexamfetamine Chewable Tabs 15)

Label for Lisdexamfetamine Dimesylate 60 mg chewable tablets, a prescription oral drug. The label indicates a quantity of 100 chewable tablets and provides storage instructions, manufacturer information (SpecGx LLC), and dispensing guidance. The tablet image shows a white, oval-shaped tablet embossed with '60'. The label also references printing a medication guide from Mallinckrodt.*

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Figure 1 (Lisdexamfetamine Chewable Tabs 2)

A forest plot labeled "Special Population" displays pharmacokinetic parameters Cmax and AUC with fold change and 90% confidence intervals relative to a reference. Populations include gender (male/female), age groups (65-74 years, 75 and older), and stages of renal impairment (mild, moderate, severe, and end stage renal disease). The x-axis shows change relative to reference from 0.0 to 2.5.*

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Figure 2 (Lisdexamfetamine Chewable Tabs 3)

A forest plot chart showing fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC of three drugs (Guanfacine, Venlafaxine, and Omeprazole) relative to a reference. The x-axis represents the change relative to the reference ranging from 0.0 to 2.0, with data points clustered near 1.0, indicating minimal change.*

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Figure 3 (Lisdexamfetamine Chewable Tabs 4)

A chart illustrating the fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of various interacting drugs, including Guanfacine, Venlafaxine, and substrates of CYP1A2, CYP2D6, CYP2C19, and CYP3A enzymes (Caffeine, Dextromethorphan, Omeprazole, Midazolam). The x-axis represents change relative to reference ranging from 0.0 to 2.0.*

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Figure 4 (Lisdexamfetamine Chewable Tabs 5)

Line graph comparing LS Mean (SE) SKAMP Deportment Scores over time post-dose (in hours) between Lisdexamfetamine Dimesylate and placebo. The graph shows separate curves for Lisdexamfetamine Dimesylate and placebo from just before administration to 13 hours after dose, illustrating changes in scores with error bars indicating variability.*

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Figure 5 (Lisdexamfetamine Chewable Tabs 6)

A Kaplan-Meier curve showing the proportion of subjects with relapse or treatment failure over time in days after randomization, comparing Lisdexamfetamine Dimesylate to placebo. The graph illustrates lower relapse rates over time for Lisdexamfetamine Dimesylate versus placebo.*

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Figure 6 (Lisdexamfetamine Chewable Tabs 7)

A line graph comparing LS Mean (SE) PERMP Total Scores over Time Post-Dose (hours) for Lisdexamfetamine Dimesylate versus Placebo. The graph shows two lines with error bars: one solid line with squares representing Lisdexamfetamine Dimesylate and a dashed line with circles for Placebo, illustrating score changes from before dosing up to 14 hours after dosing.*

FDA Label Image

Figure (Lisdexamfetamine Chewable Tabs 8)

A line chart comparing the proportion of subjects with relapse or treatment failure over time in days after randomization for Lisdexamfetamine Dimesylate versus placebo. The x-axis represents time in days, and the y-axis shows the proportion of subjects with relapse or treatment failure as a percentage. The chart includes a solid line for Lisdexamfetamine Dimesylate and a dashed line for placebo.*

FDA Label Image

Figure 8 (Lisdexamfetamine Chewable Tabs 9)

A line graph showing the proportion of subjects with relapse over time (days after randomization) comparing Lisdexamfetamine Dimesylate to placebo. The graph includes a solid line for Lisdexamfetamine Dimesylate and a dashed line for placebo, with the proportion of relapse on the vertical axis and time in days on the horizontal axis. A table below the graph displays the number of subjects at risk in each group at various time points.*

* 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.