Search by Drug Name or NDC

NDC 69842-0862-25 Stool Softener 100 mg/1 Details

Stool Softener 100 mg/1

Stool Softener is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 69842-0862-25
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69842-0862
Product ID	69842-862_51e5ab39-3077-4422-8d49-9666baf1519e
Associated GPIs	46500010300110
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	Stool Softener
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	CVS Pharmacy
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 69842-0862-25 (69842086225)

Pricing Information	N/A
NDC Package Code	69842-862-25
Billing NDC	69842086225
Package	1 BOTTLE, PLASTIC in 1 BOX (69842-862-25) / 25 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c7 Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if

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

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition
you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take with a glass of water

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

Other information

each softgel contains: sodium 5 mg
store 25ºC (77ºF); excursion 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*

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Gentle, softening relief

SOFTGELS

*This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

CVS HEALTH Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-862
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)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-862-25	1 in 1 BOX	01/31/2020
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:69842-862-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/31/2020

Labeler - CVS Pharmacy (062312574)

Revised: 10/2022

Document Id: 51e5ab39-3077-4422-8d49-9666baf1519e

Set id: 89d2e4cf-b6f6-4c96-97bb-2e4b3dc852c7

Version: 3

Effective Time: 20221010