Search by Drug Name or NDC

NDC 41163-0853-20 Stool Softener Laxative 100 mg/1 Details

Stool Softener Laxative 100 mg/1

Stool Softener Laxative is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by EQUALINE (SuperValu). 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: 41163-0853-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	41163-0853
Product ID	41163-853_d32b51d3-a168-458b-8142-10b4ab140f0b
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 Laxative
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	EQUALINE (SuperValu)
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 41163-0853-20 (41163085320)

Pricing Information	N/A
NDC Package Code	41163-853-20
Billing NDC	41163085320
Package	200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (41163-853-20)
Marketing Start Date	2021-03-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 95bae7bf-f240-4674-9e3c-640a603fdc35 Details

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told 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 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 (1-800-222-1222) 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 6 mg
store at 25o C (77o F); excursions permitted between 15- 30o C (59o- 86o F)

Inactive Ingredients

black iron oxide, D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

Call toll free 1-855-423-2630

Principal display panel

compare to Colace® Regular Strength Stool Softener active ingredient†

stool softener

docusate sodium 100 mg

Stool Softener Laxative

relieves constipation

softgels

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

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

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Product Label

EQUALINE Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-853
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 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)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	red, white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-853-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021
2	NDC:41163-853-20	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/26/2021

Labeler - EQUALINE (SuperValu) (006961411)

Revised: 11/2022

Document Id: d32b51d3-a168-458b-8142-10b4ab140f0b

Set id: 95bae7bf-f240-4674-9e3c-640a603fdc35

Version: 2

Effective Time: 20221107