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NDC 70677-0027-01 Stool Softener 240 mg/1 Details

Stool Softener 240 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 70677-0027-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	70677-0027
Product ID	70677-0027_2483a725-3107-455e-bd8c-d96bcf174f6b
Associated GPIs
GCN Sequence Number	003005
GCN Sequence Number Description	docusate calcium CAPSULE 240 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09061
HICL Sequence Number	001324
HICL Sequence Number Description	DOCUSATE CALCIUM
Brand/Generic	Generic
Proprietary Name	Stool Softener
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	Strategic Sourcing Services LLC
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 70677-0027-01 (70677002701)

Pricing Information	N/A
NDC Package Code	70677-0027-1
Billing NDC	70677002701
Package	1 BOTTLE, PLASTIC in 1 BOX (70677-0027-1) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2017-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aeb52986-f508-4a04-8604-1465b7eb5fd6 Details

Active ingredient (in each softgel)

Docusate calcium 240 mg

Purpose

Stool softener laxative

Uses

for relief of occasional constipation
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, D&C red #33*, edible white ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, purified water, sorbitol special

*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 SURFAK® ACTIVE INGREDIENT**

Stool Softener

For gentle relief of constipation

DOCUSATE CALCIUM

SOFTGELS

GLUTEN FREE

*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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Another Quality Product

Distributed By McKesson

One Post Street, San Francisco, CA 94104

Please visit us at www.sunmarkbrand.com

Product Label

SUNMARK Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0027
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)
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)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P58;SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70677-0027-1	1 in 1 BOX	03/31/2017	03/29/2024
1		100 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	03/31/2017	03/29/2024

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 11/2021

Document Id: 2483a725-3107-455e-bd8c-d96bcf174f6b

Set id: aeb52986-f508-4a04-8604-1465b7eb5fd6

Version: 4

Effective Time: 20211101