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NDC 70000-0365-03 Stool Softener 100 mg/1 Details

Stool Softener 100 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0365-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	70000-0365
Product ID	70000-0365_ecfb6a9c-4f35-442e-ae23-80c8eae05687
Associated GPIs	46500010300110
GCN Sequence Number	003009
GCN Sequence Number Description	docusate sodium CAPSULE 100 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09101
HICL Sequence Number	001326
HICL Sequence Number Description	DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Stool Softener
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	Cardinal Health (Leader) 70000
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 70000-0365-03 (70000036503)

Pricing Information
NDC Package Code	70000-0365-3
Billing NDC	70000036503
Package	750 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0365-3)
Marketing Start Date	2018-06-30
NDC Exclude Flag	N
Price Per Unit	0.02018
Pricing Unit	EA
Effective Date	2022-05-18
NDC Description	STOOL SOFTENER 100 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-05-18

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b73048a3-f419-490b-ba10-e14d9dd9c843 Details

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

relieves occasional constipation (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 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

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

adults and children 12 years 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 at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Stool Softener Laxative

Docusate Sodium 100 mg

Gentle, Dependable

Stimulant-Free for

Comfortable Relief

SOFTGELS

COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER active ingredient**

**This product is not manufactured or distributed by Purdue Products LP., distributor of Colace® Regular Strength Stool Softener

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

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Product Label

LEADER Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0365
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)

Product Characteristics
Color	red, white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P10;SCU2;D1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0365-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2018
2	NDC:70000-0365-3	750 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2018
3	NDC:70000-0365-2	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/30/2018

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 11/2022

Document Id: ecfb6a9c-4f35-442e-ae23-80c8eae05687

Set id: b73048a3-f419-490b-ba10-e14d9dd9c843

Version: 7

Effective Time: 20221110