Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate Capsule, Extended Release
Product Images NDC 31722-189

11 FDA label images from Camber Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

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 31722-189). 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)

10mg (10mg)
Label for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate extended-release capsules, 10 mg strength. The package contains 100 capsules and is a prescription drug by Camber Pharmaceuticals, Inc. The label includes storage instructions, manufacturer details, and medication guide information.*
FDA Label Image

15mg (15mg)

15mg (15mg)
Label for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules, 15 mg strength. The label indicates the product is supplied in a bottle of 100 capsules, prescription use only, and manufactured by Camber Pharmaceuticals, Inc. Storage and dispensing instructions are provided along with a note to dispense the accompanying medication guide.*
FDA Label Image

20mg (20mg)

20mg (20mg)
Label for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules, 20 mg strength, manufactured by Camber Pharmaceuticals, Inc. The label indicates a package of 100 capsules, Rx only, with storage instructions and a note to dispense the accompanying medication guide. It details the composition per capsule and includes the NDC number 31722-188-01.*
FDA Label Image

25mg (25mg)

25mg (25mg)
Label for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules 25 mg by Camber Pharmaceuticals, Inc. The label indicates a package size of 100 capsules and includes storage instructions and regulatory information. It notes this product is Rx only and includes directions for pharmacists to dispense the medication guide.*
FDA Label Image

30mg (30mg)

30mg (30mg)
Label for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules, 30 mg strength. The label indicates 100 capsules per container, with prescription-only status, and is manufactured by Camber Pharmaceuticals, Inc. Additional storage and dispensing instructions are also visible.*
FDA Label Image

5mg (5mg)

5mg (5mg)
Label for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate extended-release capsules, 5 mg strength, containing 100 capsules. The label includes dosing information, storage instructions, manufacturer (Ascent Pharmaceuticals, Inc.), and labeler (Camber Pharmaceuticals, Inc.).*
FDA Label Image

Figure1 (Fig1)

Figure1 (Fig1)
A line graph depicting mean plasma concentrations of dextroamphetamine and levoamphetamine (ng/mL) over 24 hours. The graph compares two products: Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules 20 mg once daily, and ADDERALL® 10 mg twice daily tablet. The x-axis shows time in hours (0–24), and the y-axis shows plasma concentrations. Separate lines represent concentrations for dextroamphetamine and levoamphetamine for both products.*
FDA Label Image

Table1 (Table1)

Table1 (Table1)
A data table listing adverse reactions reported by 2% or more of children aged 6-12 years receiving dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules compared with placebo. The table categorizes side effects by body system, preferred term, and reports incidence percentages for both drug (n=374) and placebo (n=210) groups in a 584-patient clinical study.*
FDA Label Image

Table2 (Table2)

Table2 (Table2)
A table listing adverse reactions reported by 5% or more of adolescents (13-17 years old) weighing 75 kg or less receiving extended-release capsules of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate compared to placebo. It shows incidence rates of abdominal pain, loss of appetite, insomnia, nervousness, and weight loss in treated patients versus placebo in a clinical study with 287 patients.*
FDA Label Image

Table3 (Table3)

Table3 (Table3)
A data table presenting adverse reactions reported by 5% or more of adults taking Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules compared to placebo in a clinical trial. The table categorizes reactions by body system, preferred adverse event terms, and frequency percentages for both treatment (n=191) and placebo (n=64) groups, including general, digestive, nervous, cardiovascular, metabolic, and urogenital systems.*
FDA Label Image

Table4 (Table4)

Table4 (Table4)
A data table detailing drug interaction information for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules. The table lists interaction categories including Monoamine Oxidase Inhibitors (MAOIs), Serotonergic Drugs, CYP2D6 Inhibitors, Alkalinizing Agents, Acidifying Agents, Tricyclic Antidepressants, and Proton Pump Inhibitors. For each, clinical impact, intervention recommendations, and example drugs are provided.*

* 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.