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NDC 69842-0893-30 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 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: 69842-0893-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69842-0893
Product ID	69842-893_062987b9-9fad-472d-9e18-98179492806d
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	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 69842-0893-30 (69842089330)

Pricing Information	N/A
NDC Package Code	69842-893-30
Billing NDC	69842089330
Package	1 BOTTLE, PLASTIC in 1 BOX (69842-893-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-07-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8d59fa14-fc7c-4146-ba59-c2a907356dd6 Details

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

Ask a doctor before use if you have

stomach pain
nausea
vomiting
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 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 softgels with a full glass (8 oz) of water

adults and children 12 years and older	take 1-3 softgels daily or as directed by a doctor. 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 or as directed by a doctor
children under 2 years	ask a doctor

Other information

each softgel contains: sodium 6 mg
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

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

Principal Display Panel

Compare to the active ingredient in Phillips'® Stool Softener*

Stool Softener

DOCUSATE SODIUM, 100 mg

Relieves occasional constipation

Stool softener laxative
Reliable relief

SOFTGELS

**This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Philips'® Stool Softener.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

CVS HEALTH 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:69842-893
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
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)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

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:69842-893-30	1 in 1 BOX	07/30/2021
1		30 in 1 BOTTLE, PLASTIC; 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	07/30/2021

Labeler - CVS Pharmacy (062312574)

Revised: 11/2022

Document Id: 062987b9-9fad-472d-9e18-98179492806d

Set id: 8d59fa14-fc7c-4146-ba59-c2a907356dd6

Version: 4

Effective Time: 20221122