Home DailyMed 272c86f1-f229-2ebf-e063-6394a90a3471 Stool Softener Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Effective date 2024-11-18
Label type HUMAN OTC DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-06-01 00:39:44 Label at a glance# Product Stool Softener
Active ingredient DOCUSATE SODIUM
Label structure 10 sections
Dosage and administration take with a glass of water -see Overdose warning adults and children 12 years of age and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses children 2 to under 12 years of age 1 softgel daily children under 2 years of age ask a doctor
Storage and handling each softgel contains: sodium 5mg store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity contains FD&C Yellow No. 6
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 1115005 docusate sodium 100 MG Oral Capsule PSN 1 1115005 docusate sodium 100 MG Oral Capsule SCD 1 1115005 DOSS Sodium 100 MG Oral Capsule SY 1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51013-819-01 Stool Softener 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-819 STOOL SOFTENER (DOCUSATE SODIUM 100MG) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] 1 Current NDC, 1 package rows 20241130_272c86f1-f229-2ebf-e063-6394a90a3471.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 13 matching rows.
Stool Softener Docusate Sodium 100mg GELATIN, UNSPECIFIED DOCUSATE SODIUM DOCUSATE PROPYLENE GLYCOL SORBITOL FD&C RED NO. 40 WATER ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 GLYCERIN Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 10 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.