Methylphenidate Hydrochloride Capsule, Extended Release
Product Images NDC 0406-1810

10 FDA label images from Specgx Llc · 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 Methylphenidate Hydrochloride (NDC 0406-1810). 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 (Methylphenidate Hydrochloride Er Capsules 1)

Chemical Structure (Methylphenidate Hydrochloride Er Capsules 1)
Chemical structure of methylphenidate hydrochloride showing its molecular formula C14H19NO2·HCl and molecular weight 269.77.*
FDA Label Image

Pdp (Methylphenidate Hydrochloride Er Capsules 10)

Pdp (Methylphenidate Hydrochloride Er Capsules 10)
Label for Methylphenidate Hydrochloride Extended-Release Capsules, 60 mg strength, containing 100 capsules. The label states once daily dosing and prescription-only status. It includes storage instructions, dosage warnings, manufacturer SpecGx LLC located in Webster Groves, MO, and a warning to dispense the Medication Guide separately. A barcode and a capsule image marked with 60 mg and 860 are also visible.*
FDA Label Image

Figure 1 (Methylphenidate Hydrochloride Er Capsules 2)

Figure 1 (Methylphenidate Hydrochloride Er Capsules 2)
A line graph comparing mean methylphenidate plasma concentrations (ng/mL) over 9 hours post-dosing for immediate-release (IR) and methylphenidate HCl extended-release (ER) capsules in children with ADHD. It shows three dosing regimens: 1x 10 mg IR at 0 and 4 hours, 1x 20 mg ER capsule, and 2x 20 mg ER capsules, with time on the x-axis and mean methylphenidate levels on the y-axis.*
FDA Label Image

Figure 2 (Methylphenidate Hydrochloride Er Capsules 3)

Figure 2 (Methylphenidate Hydrochloride Er Capsules 3)
A bar chart titled 'Least Squares Mean Change from Baseline in TCGIS Scores' comparing Methylphenidate HCl USP Extended-Release Capsules (n=155) and placebo (n=159). The vertical axis shows least squares mean change from baseline, with Methylphenidate capsules showing a greater decrease (-7.9) than placebo (-1.2). Error bars indicate variability for both groups.*
FDA Label Image

Figure 3 (Methylphenidate Hydrochloride Er Capsules 4)

Figure 3 (Methylphenidate Hydrochloride Er Capsules 4)
Bar chart showing least squares mean change from baseline in TCGIS scores comparing Methylphenidate HCl USP Extended-Release Capsules and placebo groups in morning (AM) and afternoon (PM) assessments. The chart includes error bars representing standard error of the mean and notes last observation carried forward analysis at week 3.*
FDA Label Image

Pdp (Methylphenidate Hydrochloride Er Capsules 5)

Pdp (Methylphenidate Hydrochloride Er Capsules 5)
Methylphenidate Hydrochloride Extended-Release Capsules 10 mg by SpecGx LLC, packaged as 100 oral capsules. The label states 'Once Daily' and 'Rx only,' with pharmacist instructions to dispense a medication guide. Storage and dosing cautions are included, along with manufacturer information from Webster Groves, MO.*
FDA Label Image

Pdp (Methylphenidate Hydrochloride Er Capsules 6)

Pdp (Methylphenidate Hydrochloride Er Capsules 6)
Label for Methylphenidate HCl Extended-Release Capsules, 20 mg strength, in a 100 capsule bottle. The label indicates once daily oral extended-release capsules with a pharmacist note to dispense the medication guide. Manufacturer is SpecGx LLC, located in Webster Groves, MO. Packaging includes storage instructions and usage warnings.*
FDA Label Image

Pdp (Methylphenidate Hydrochloride Er Capsules 7)

Pdp (Methylphenidate Hydrochloride Er Capsules 7)
Label for Methylphenidate Hydrochloride Extended-Release Capsules showing 30 mg strength. The label indicates the product is for prescription use only, labeled 'Once Daily Methylphenidate HCl Extended-Release Capsules 30 mg' with a CII controlled substance symbol. It includes dispensing instructions for pharmacists and storage directions. The manufacturer is SpecGx LLC.*
FDA Label Image

Pdp (Methylphenidate Hydrochloride Er Capsules 8)

Pdp (Methylphenidate Hydrochloride Er Capsules 8)
Label for Methylphenidate Hydrochloride Extended-Release Capsules 40 mg by SpecGx LLC. The label states 'Once Daily' dosing and indicates 100 capsules per container. It includes warnings, storage instructions, and mandates pharmacist dispensing of a medication guide. Capsule imprint shows 'M 840' and '40 mg.' Manufacturer is Mallinckrodt, Webster Groves, MO.*
FDA Label Image

Pdp (Methylphenidate Hydrochloride Er Capsules 9)

Pdp (Methylphenidate Hydrochloride Er Capsules 9)
Label for Methylphenidate Hydrochloride Extended-Release Capsules, 50 mg strength, oral extended-release capsules, in a package of 100 capsules. The label includes dosage instructions to take once daily, a note that it is prescription only, and storage instructions. The medication is manufactured by SpecGx LLC, Webster Groves, MO. The label also features a barcode and capsule image marked with the strength 50 mg and identifier M 1850.*

* 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.