Dyanavel Xr Tablet, Extended Release
Product Images NDC 24478-108

19 FDA label images from Nextwave Pharmaceuticals, Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Dyanavel Xr (NDC 24478-108). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nextwave Pharmaceuticals, 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

Dxr Chem Draw Structure (Dyanavel Xr Oral Suspension And Tablets 1)

Dxr Chem Draw Structure (Dyanavel Xr Oral Suspension And Tablets 1)
Chemical structure of amphetamine, the active ingredient in DYANAVEL XR extended release tablets.*
FDA Label Image

Step6 (Dyanavel Xr Oral Suspension And Tablets 10)

Step6 (Dyanavel Xr Oral Suspension And Tablets 10)
An instructional illustration showing hands demonstrating how to extract liquid medication from a bottle using a syringe. One hand holds the bottle upside down while the other pulls the syringe plunger to draw the liquid. A close-up circular inset highlights the syringe tip inserted into the bottle's opening.*
FDA Label Image

Step7 (Dyanavel Xr Oral Suspension And Tablets 11)

Step7 (Dyanavel Xr Oral Suspension And Tablets 11)
An instructional illustration showing one hand holding a bottle and the other hand drawing liquid from the bottle into a syringe. The image appears to demonstrate the correct procedure for using an oral dosing syringe with a medication bottle.*
FDA Label Image

Step8 (Dyanavel Xr Oral Suspension And Tablets 12)

Step8 (Dyanavel Xr Oral Suspension And Tablets 12)
An instructional illustration showing a child receiving oral medication from a syringe held by an adult. The child opens their mouth to take the dose, demonstrating a method of administering liquid medication orally.*
FDA Label Image

Step9 (Dyanavel Xr Oral Suspension And Tablets 13)

Step9 (Dyanavel Xr Oral Suspension And Tablets 13)
An instructional illustration showing a hand turning the child-resistant cap of a bottle counterclockwise to open it. The image demonstrates how to remove the cap from the bottle, which features a safety seal on top.*
FDA Label Image

Step10 (Dyanavel Xr Oral Suspension And Tablets 14)

Step10 (Dyanavel Xr Oral Suspension And Tablets 14)
An instructional diagram showing two hands demonstrating how to use an oral syringe. The left side shows a hand placing the syringe tip into a cup, and the right side illustrates expelling liquid from the syringe tip by pressing the plunger.*
FDA Label Image

16oz Label (Dyanavel Xr Oral Suspension And Tablets 15)

16oz Label (Dyanavel Xr Oral Suspension And Tablets 15)
Dyanavel XR 2.5 mg/mL extended-release oral suspension label with amphetamine as the active ingredient. The label shows the proprietary name Dyanavel XR and the dosage strength of 2.5 mg/mL. It includes instructions to shake well before use, the volume of 464 mL, and storage information. The label also lists the manufacturer NextWave Pharmaceuticals, Inc. (trademarked as Tris Pharma) and includes pharmacist dispensing instructions.*
FDA Label Image

5mg Label (Dyanavel Xr Oral Suspension And Tablets 16)

5mg Label (Dyanavel Xr Oral Suspension And Tablets 16)
Label for Dyanavel XR 5 mg extended-release tablets containing amphetamine. The label indicates the tablets may be chewed or swallowed whole and includes dosage and storage instructions. It also states the product is manufactured by Tris Pharma, Inc., and comes in a 30-tablet container with a child-resistant closure.*
FDA Label Image

10mg Label (Dyanavel Xr Oral Suspension And Tablets 17)

10mg Label (Dyanavel Xr Oral Suspension And Tablets 17)
Dyanavel XR 10 mg extended-release tablets containing amphetamine base label. The label indicates each tablet contains 10 mg of amphetamine, can be chewed or swallowed, and includes a 30-tablet count. It is manufactured by Tris Pharma, Inc., with storage and dosage instructions, warnings, and barcode visible on the label.*
FDA Label Image

15mg Label (Dyanavel Xr Oral Suspension And Tablets 18)

15mg Label (Dyanavel Xr Oral Suspension And Tablets 18)
Label for DYANAVEL XR 15 mg extended-release tablets containing amphetamine. The label shows a yellow highlight of 15 mg strength and notes that tablets may be chewed or swallowed whole. It instructs to keep out of reach of children, provides storage conditions, and states the labeler as NextWave Pharmaceuticals, Inc. Manufacturing information is provided for Tris Pharma, Inc. The package contains 30 tablets.*
FDA Label Image

20mg Label (Dyanavel Xr Oral Suspension And Tablets 19)

20mg Label (Dyanavel Xr Oral Suspension And Tablets 19)
DYANAVEL XR 20 mg extended-release tablets label by NextWave Pharmaceuticals, Inc. The label shows the proprietary name, generic name amphetamine, dosage form as extended-release tablets, strength 20 mg, and route oral. It includes consumption instructions, pharmacist warnings, manufacturer Tris Pharma, Inc. information, and packaging details for 30 tablets.*
FDA Label Image

Figure1 (Dyanavel Xr Oral Suspension And Tablets 2)

Figure1 (Dyanavel Xr Oral Suspension And Tablets 2)
A pharmacokinetic curve depicting plasma amphetamine concentration (ng/mL) over time (hours) for different formulations and enantiomers of amphetamine. The graph compares DYANAVEL XR 7.5 mL (equivalent to 18.8 mg amphetamine base) and MAS ER 30 mg (equivalent to 18.8 mg amphetamine base) for both l-amphetamine and d-amphetamine enantiomers up to 60 hours post-dose.*
FDA Label Image

Figure2 (Dyanavel Xr Oral Suspension And Tablets 3)

Figure2 (Dyanavel Xr Oral Suspension And Tablets 3)
A pharmacokinetic concentration-time curve graph showing plasma concentrations of l-amphetamine and d-amphetamine from DYANAVEL XR 20 mg formulations over 60 hours. The chart compares chewed, swallowed whole tablets, and oral suspension at different time points, with concentration (ng/mL) on the y-axis and time (hours) on the x-axis.*
FDA Label Image

Figure3 (Dyanavel Xr Oral Suspension And Tablets 4)

Figure3 (Dyanavel Xr Oral Suspension And Tablets 4)
A line graph comparing the effect of Dyanavel XR and placebo over 13 hours post-dose. The x-axis shows hours post-dose, and the y-axis shows the least squares (LS) mean with standard error. Dyanavel XR data points decrease below zero over time, while placebo data points remain above zero, indicating a difference in response between the two groups.*
FDA Label Image

Step1a (Dyanavel Xr Oral Suspension And Tablets 5)

Step1a (Dyanavel Xr Oral Suspension And Tablets 5)
An instructional illustration depicting a hand holding a bottle and showing how to attach a bottle adapter on top of it. The bottle adapter is a small, threaded cylindrical piece designed to fit securely onto the bottle opening.*
FDA Label Image

Step1 (Dyanavel Xr Oral Suspension And Tablets 6)

Step1 (Dyanavel Xr Oral Suspension And Tablets 6)
An illustration showing a clear glass bottle with liquid and an oral dosing dispenser syringe beside it, used for administering oral liquid medication.*
FDA Label Image

Step2 (Dyanavel Xr Oral Suspension And Tablets 7)

Step2 (Dyanavel Xr Oral Suspension And Tablets 7)
An instructional illustration showing a hand holding a bottle and shaking it with a vertical arrow indicating up and down motion, likely demonstrating the recommended way to mix or prepare the liquid medication before use.*
FDA Label Image

Step3 (Dyanavel Xr Oral Suspension And Tablets 8)

Step3 (Dyanavel Xr Oral Suspension And Tablets 8)
Illustration showing a syringe with measurement markings from 1 mL to 4 mL. The image appears to demonstrate usage or measurement related to liquid dosing, likely associated with a medication in solution form.*
FDA Label Image

Step4_5 (Dyanavel Xr Oral Suspension And Tablets 9)

Step4_5 (Dyanavel Xr Oral Suspension And Tablets 9)
An instructional illustration showing a hand holding a bottle and another hand pressing down on the plunger of a syringe or dropper, demonstrating how to withdraw liquid from the bottle.*

* 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.