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NDC 59779-0852-25 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED 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: 59779-0852-25
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	59779-0852
Product ID	59779-852_3eaa7420-ca92-442b-9591-9596574f42fa
Associated GPIs	46500010300120
GCN Sequence Number	003011
GCN Sequence Number Description	docusate sodium CAPSULE 250 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09102
HICL Sequence Number	001326
HICL Sequence Number Description	DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Stool Softener
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	DOCUSATE SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	250
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	n/a

Package

Package Images

NDC 59779-0852-25 (59779085225)

Pricing Information	N/A
NDC Package Code	59779-852-25
Billing NDC	59779085225
Package	250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59779-852-25)
Marketing Start Date	2014-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f779c0ff-8fe9-4b37-8830-cb96a07abca8 Details

Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 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 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 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 right away.

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Other information

each softgel contains: sodium 15 mg
store at 20º-25ºC(68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol special

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Colace® Stool Softener**

EXTRA STRENGTH

Stool Softener

DOCUSATE SODIUM, 250 mg

Relieves Constipation

Gentle stool softener
reliable relief
stimulant free

SOFTGELS

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

CVS.com

1-800-SHOP CVS

Product Label

CVS HEALTH Extra Strength Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER EXTRA STRENGTH

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-852
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
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)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P20;SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-852-25	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2014	12/31/2023
2	NDC:59779-852-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2014	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/30/2014	12/31/2023

Labeler - CVS Pharmacy (062312574)

Revised: 10/2021

Document Id: 3eaa7420-ca92-442b-9591-9596574f42fa

Set id: f779c0ff-8fe9-4b37-8830-cb96a07abca8

Version: 7

Effective Time: 20211013

Search by Drug Name or NDC

NDC 59779-0852-25 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 59779-0852-25 (59779085225)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f779c0ff-8fe9-4b37-8830-cb96a07abca8 Details

Active ingredient (in each softgel)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep out of reach of children.

Directions

Other information

Inactive Ingredients

Questions or comments?

Principal Display Panel

Product Label

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 59779-0852-25 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 59779-0852-25 (59779085225)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f779c0ff-8fe9-4b37-8830-cb96a07abca8 Details

Active ingredient (in each softgel)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep out of reach of children.

Directions

​​Other information

Inactive Ingredients

Questions or comments?

Principal Display Panel

Product Label

INGREDIENTS AND APPEARANCE

Other information