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NDC 69842-0868-10 Stool Softener Laxative 240 mg/1 Details

Stool Softener Laxative 240 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 CALCIUM.

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: 69842-0868-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	69842-0868
Product ID	69842-868_8bdb6c84-caff-4d94-8cba-b7f70c39c90a
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 calcium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	240
Active Ingredient Units	mg/1
Substance Name	DOCUSATE CALCIUM
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 69842-0868-10 (69842086810)

Pricing Information	N/A
NDC Package Code	69842-868-10
Billing NDC	69842086810
Package	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-868-10)
Marketing Start Date	2019-12-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf Details

Active ingredient (in each softgel)

Docusate calcium 240 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

if you are currently 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 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 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

store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

corn oil, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, purified water, sorbitan, sorbitol

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Surfak®*

Stool Softener

DOCUSATE CALCIUM, 240 mg

Stool Softener Laxative

Sodium Free

Gentle relief of constipation
Once-a-day dosage

SOFTGELS

*This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®.

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

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE

docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-868
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Ingredient Name	Strength
Inactive Ingredients
CORN OIL (UNII: 8470G57WFM)
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)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-868-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/27/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/27/2019

Labeler - CVS Pharmacy (062312574)

Revised: 11/2022

Document Id: 8bdb6c84-caff-4d94-8cba-b7f70c39c90a

Set id: cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf

Version: 3

Effective Time: 20221122