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NDC 69842-0169-48 STOOL SOFTENER 100 mg/1 Details

STOOL SOFTENER 100 mg/1

STOOL SOFTENER is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY, 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: 69842-0169-48
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69842-0169
Product ID	69842-169_468f2bab-b388-4bfc-af88-abacdd46a129
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	STOOL SOFTENER
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCUSATE SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	CVS PHARMACY, 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 69842-0169-48 (69842016948)

Pricing Information	N/A
NDC Package Code	69842-169-48
Billing NDC	69842016948
Package	1 BOTTLE in 1 CARTON (69842-169-48) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date	2018-02-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9665721c-40bf-4674-8430-399c70bdca47 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
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 lasts 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 signs of a serious condition.
you need to use a stool softener 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 right away.

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1 - 3 softgels daily
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
VERY LOW SODIUM
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

anhydrous citric acid, black ink, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white dispersion G.B

Questions or comments?

Call toll free: 1-855-215-8180

Principal Display Panel - Bottle Label

STOOL SOFTENER

DOCUSATE SODIUM 100mg 10 Softgels

Compare to the active ingredient in COLACE

NDC 69842-169-48

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-169
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red, white (Two-Tone)	Score	no score
Shape	capsule (Oval)	Size	13mm
Flavor		Imprint Code	PC18
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-169-48	1 in 1 CARTON	02/12/2018
1		10 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/12/2018

Labeler - CVS PHARMACY, INC. (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69842-169) , analysis(69842-169)

Revised: 11/2019

Document Id: 468f2bab-b388-4bfc-af88-abacdd46a129

Set id: 9665721c-40bf-4674-8430-399c70bdca47

Version: 3

Effective Time: 20191122