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NDC 71335-0632-02 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 71335-0632-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	71335-0632
Product ID	71335-0632_7ff5b843-e930-4718-804b-c6e0d555b29d
Associated GPIs	46500010300120
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
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Docusate Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Bryant Ranch Prepack
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 71335-0632-02 (71335063202)

Pricing Information	N/A
NDC Package Code	71335-0632-2
Billing NDC	71335063202
Package	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0632-2)
Marketing Start Date	2018-01-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ed53b4fb-c1aa-4738-b2dd-8a2f9c75e39b Details

Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are presently 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

each softgel contains:sodium 15 mg
store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

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

*may contain this ingredient

Questions or comments?

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

HOW SUPPLIED

Product: 71335-0632

NDC: 71335-0632-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0632-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0632-3 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0632-4 7 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 250mg Capsule

INGREDIENTS AND APPEARANCE

STOOL SOFTENER EXTRA STRENGTH

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0632(NDC:0536-1064)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P20;SCU1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0632-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2018
2	NDC:71335-0632-4	7 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2018
3	NDC:71335-0632-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2018
4	NDC:71335-0632-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/31/2015

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0632) , RELABEL(71335-0632)

Revised: 1/2020

Document Id: 7ff5b843-e930-4718-804b-c6e0d555b29d

Set id: ed53b4fb-c1aa-4738-b2dd-8a2f9c75e39b

Version: 3

Effective Time: 20200119

Search by Drug Name or NDC

NDC 71335-0632-02 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-0632-02 (71335063202)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ed53b4fb-c1aa-4738-b2dd-8a2f9c75e39b Details

Active ingredient (in each softgel)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

HOW SUPPLIED

Docusate Sodium 250mg Capsule

INGREDIENTS AND APPEARANCE

Migranal Generic Name Question

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Search by Drug Name or NDC

NDC 71335-0632-02 Stool Softener 250 mg/1 Details

Stool Softener 250 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-0632-02 (71335063202)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ed53b4fb-c1aa-4738-b2dd-8a2f9c75e39b Details

Active ingredient (in each softgel)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients​

Questions or comments?

HOW SUPPLIED

Docusate Sodium 250mg Capsule

INGREDIENTS AND APPEARANCE

Inactive ingredients