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NDC 69842-0483-10 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: 69842-0483-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69842-0483
Product ID	69842-483_ee61769a-93ec-4ab2-b127-d35248b78b69
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
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	n/a

Package

Package Images

NDC 69842-0483-10 (69842048310)

Pricing Information	N/A
NDC Package Code	69842-483-10
Billing NDC	69842048310
Package	100 CAPSULE in 1 BOTTLE, PLASTIC (69842-483-10)
Marketing Start Date	2019-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14b07437-c0ba-4a21-8926-5e613f461286 Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

relieves of occasional constipation and 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

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

adults and children 12 over 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 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

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Colace® Regular Strength Stool Softener

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Gentle, softening relief

SOFTGELS

†This product is not manufactured or distributed by Purdue Products 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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

CVS HEALTH Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-483
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;SCU1;D2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-483-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2019	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/01/2019	12/31/2023

Labeler - CVS Pharmacy (062312574)

Revised: 10/2021

Document Id: ee61769a-93ec-4ab2-b127-d35248b78b69

Set id: 14b07437-c0ba-4a21-8926-5e613f461286

Version: 3

Effective Time: 20211018