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NDC 49035-0584-25 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 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). 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: 49035-0584-25
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	49035-0584
Product ID	49035-584_786ad1ac-0c46-4f74-afad-3d3958c34440
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	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
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 49035-0584-25 (49035058425)

Pricing Information	N/A
NDC Package Code	49035-584-25
Billing NDC	49035058425
Package	1 BOTTLE, PLASTIC in 1 BOX (49035-584-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1596148-101f-45a8-8405-e2aee02b92e7 Details

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Ask a doctor before use if you have

stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using 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 with a glass of water

adults and children 12 years and over	take 1 to 3 softgels daily. 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
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

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol

*may contain one or more of these ingredients

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to DulcoEase® Stool Softener Active Ingredient†

Stool Softener

Docusate Sodium 100 mg

Stool Softener Laxative

Comfortable relief of painful, hard, dry stools
Stimulant-Free
Constipation relief

SOFTGELS

†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of DulcoEase®.

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: Wal-Mart Stores, Inc.,

Bentonville,AR 72716

Product Labeling

EQUATE Stool Softener Laxative Softgels

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-584
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)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

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:49035-584-25	1 in 1 BOX	01/31/2018	01/31/2025
1		25 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	01/31/2018	01/31/2025

Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 10/2022

Document Id: 786ad1ac-0c46-4f74-afad-3d3958c34440

Set id: b1596148-101f-45a8-8405-e2aee02b92e7

Version: 3

Effective Time: 20221025