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NDC 50804-0862-25 Docusate Sodium 100 mg/1 Details

Docusate Sodium 100 mg/1

Docusate Sodium is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, Inc.). The primary component is DOCUSATE SODIUM.

MedlinePlus Drug Summary

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 50804-0862-25
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	50804-0862
Product ID	50804-862_098ab208-0beb-4869-8d20-0dae9686cd13
Associated GPIs
GCN Sequence Number	003009
GCN Sequence Number Description	docusate sodium CAPSULE 100 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09101
HICL Sequence Number	001326
HICL Sequence Number Description	DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Docusate Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCUSATE SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Good Sense (Geiss, Destin & Dunn, Inc.)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0862-25 (50804086225)

Pricing Information	N/A
NDC Package Code	50804-862-25
Billing NDC	50804086225
Package	25 CAPSULE in 1 BOTTLE, PLASTIC (50804-862-25)
Marketing Start Date	2021-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d729ceac-2eef-40c0-bb1a-f8d80290c60f Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

for relief of occasional constipation (irregularity)
this product generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

take with a glass of water

adults and children 12 years and over	take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided dose
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

each softgel contains: sodium 5 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Dulcolax® Stool Softener

Gentle

Stool Softener

Docusate Sodium

Stool Softener Laxative

For Gentle Softener Relief

Stimulant-free

Softgels

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

Product Label

GOOD SENSE Stool Softener

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-862
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
SORBITAN (UNII: 6O92ICV9RU)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-862-25	25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/28/2021

Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

Revised: 11/2022

Document Id: 098ab208-0beb-4869-8d20-0dae9686cd13

Set id: d729ceac-2eef-40c0-bb1a-f8d80290c60f

Version: 3

Effective Time: 20221107