Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate Capsule, Extended Release
Product Images NDC 31722-187

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate (NDC 31722-187). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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

10mg (10mg)

This text represents pharmaceutical information for extended-release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. The capsules must be stored at a controlled room temperature and dispensed in a light-resistant container as defined in the USP. The medication guide is available for patients, and the capsules are manufactured by Ascent Pharmaceuticals. The text provides a complete list of the medication's ingredients and dosage equivalence.*

FDA Label Image

15mg (15mg)

This text appears to be a medication label that provides information on how to store and use extended-release capsules containing a mixture of amphetamine salts. It also includes information on the amount of the medication in each capsule and provides a manufacturer's name and medication guide for patients. The medication is intended to be dispensed by pharmacists with a prescription.*

FDA Label Image

20mg (20mg)

This appears to be a medication label containing information such as storage instructions and the ingredients of an extended-release capsule for treating Attention-Deficit/Hyperactivity Disorder (ADHD). The medication contains a mixture of amphetamine salts and is intended for prescription use only. The label also includes contact information for the manufacturer and a reminder for pharmacists to provide patients with a medication guide.*

FDA Label Image

25mg (25mg)

FDA Label Image

30mg (30mg)

This is a medication guide for Dextroamphetamine Saccharate that contains extended-release capsules of amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. The medication is to be stored at 20° to 25°C (68° to 77°F) and dispensed in a light-resistant container. Detailed information can be found in the package insert. The medication is manufactured by Ascent Pharmaceutical, Inc. A medication guide is also included for each patient.*

FDA Label Image

5mg (5mg)

This is a medication guide for extended-release capsules containing Amphetamine Aspartate Monohydrate, Dextroamphetamine Saccharate, and Amphetamine Sulfate for the treatment of attention deficit hyperactivity disorder (ADHD). It provides information on dosage, storage requirements, and precautions, including the permitted temperature range for storage. The medication should be dispensed with an accompanying patient guide, and the complete package insert should be consulted for more information.*

FDA Label Image

Figure1 (Fig1)

This is a table displaying the mean plasma concentrations of dextro and levoamphetamine measured in ng/mL at different time intervals ranging from 12 to 30 hours.*

FDA Label Image

Table1 (Table1)

This is a table presenting adverse reactions reported by more than 2% of children aged 6-12 receiving Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules with a higher incidence than on placebo in a clinical study involving 584 patients. Adverse reactions listed include abdominal pain, fever, infection, accidental injury, fatigue, loss of appetite, vomiting, nausea, dyspepsia, insomnia, emotional lability, nervousness, dizziness, and weight loss.*

FDA Label Image

Table2 (Table2)

This is a table of adverse reactions reported by adolescents (13-17 years old) receiving dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules with a higher incidence than placebo. The table shows adverse reactions that were reported with a frequency of 5% or more including abdominal pain, loss of appetite, insomnia, nervousness, and weight loss. Other adverse reactions reported by 2% to 4% of adolescents included accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting.*

FDA Label Image

Table3 (Table3)

The text provides tables displaying the adverse reactions reported by more than 5% of adults receiving Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules in a clinical study, including their incidence rate compared to placebo. The study included doses up to 60 mg. The text also notes that there were additional reactions reported by 2%-4% of patients receiving the medication with a higher incidence than patients receiving placebo.*

FDA Label Image

Table4 (Table4)

The text describes the clinical impact and possible interventions regarding the concomitant use of Maoi inhibitors and CNS stimulants, such as dexfroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, that could lead to severe conditions like serotonin syndrome. The text also warns against the use of CYP2D6 inhibitors, alkalinizing agents, tricyclic antidepressants, and proton pump inhibitors in combination with the aforementioned stimulants and advises caution and monitoring in each case.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.