Lubiprostone Capsule
Product Images NDC 31722-404

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Lubiprostone (NDC 31722-404). 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.

Product Images & Figures Index

FDA Label Image

24mcg-60s (24mcg 60s)

24mcg-60s (24mcg 60s)
Label for Lubiprostone Capsules 24 mcg oral dosage form by Camber Pharmaceuticals, Inc. The label states 'Swallow Whole - Do NOT Break Apart or Chew' and indicates a package size of 60 capsules. It includes storage instructions and manufacturing details from Ascent Pharmaceuticals and Camber Pharmaceuticals. The label also features a barcode and highlights 'NO VARNISH'.*
FDA Label Image

8mcg-60s (8mcg 60s)

8mcg-60s (8mcg 60s)
Label for Lubiprostone Capsules 8 mcg by Camber Pharmaceuticals, Inc. The label states the product is oral capsules with a quantity of 60 capsules per container. It includes storage instructions, manufacturing details, and a note that capsules should be swallowed whole without breaking or chewing.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of the active ingredient lubiprostone, showing its molecular configuration with oxygen, hydrogen, fluorine, and carbon atoms arranged in a complex ring and side chain structure.*
FDA Label Image

Table 2 (Table 2)

Table 2 (Table 2)
A table presenting adverse reactions in clinical trials of adults with chronic idiopathic constipation (CIC) comparing placebo and Lubiprostone Capsules 24 mcg twice daily. It lists various adverse reactions with corresponding percentages for placebo (N=316) and Lubiprostone (N=1113) groups, including nausea, diarrhea, headache, abdominal pain, and other gastrointestinal and systemic symptoms.*
FDA Label Image

Table-1 (Table 1)

Table-1 (Table 1)
A data table titled 'Recommended Dosage Regimen' detailing adult dosage regimens and hepatic impairment dose adjustments for lubiprostone. It compares dosages for CIC and OIC (24 mcg twice daily) and IBS-C (8 mcg twice daily), including specified dose modifications for moderate and severe hepatic impairment based on Child-Pugh classifications.*
FDA Label Image

Table-3 (Table 3)

Table-3 (Table 3)
A clinical trial data table showing adverse reactions in adults with OIC comparing placebo (632 subjects) and lubiprostone capsules 24 mcg twice daily (860 subjects). It lists the percentage of patients experiencing nausea, diarrhea, abdominal pain, flatulence, abdominal distension, vomiting, headache, peripheral edema, and abdominal discomfort.*
FDA Label Image

Table-4 (Table 4)

Table-4 (Table 4)
A table presenting adverse reactions in clinical trials of adults with IBS-C comparing placebo and Lubiprostone Capsules 8 mcg taken twice daily. It lists the percentage of patients experiencing nausea, diarrhea, abdominal pain, and abdominal distension for both groups.*
FDA Label Image

Table-5 (Table 5)

Table-5 (Table 5)
A data table titled "Pharmacokinetic Parameters of the Metabolite M3 for Subjects with Normal or Impaired Liver Function following Dosing with Lubiprostone Capsules." The table shows liver function status categories (Normal, Child-Pugh Class B, Class C) with corresponding mean and standard deviation (SD) values for AUC and Cmax, along with percentage changes versus normal for each parameter.*
FDA Label Image

Table-6 (Table 6)

Table-6 (Table 6)
A data table titled 'Adult Spontaneous Bowel Movement Frequency Rates (Efficacy Studies)' showing baseline and weekly mean, standard deviation, and median values for spontaneous bowel movements. The table compares placebo and Lubiprostone Capsules 24 mcg taken twice daily across two study arms, detailing changes from baseline through week 4.*

* 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.