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NDC 71335-0738-03 STOOL SOFTNER 100 mg/1 Details

STOOL SOFTNER 100 mg/1

STOOL SOFTNER 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: 71335-0738-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	71335-0738
Product ID	71335-0738_2ef0bb0f-6168-4d4c-9ede-d940b5afbe4b
Associated GPIs	46500010300110
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 SOFTNER
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	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 71335-0738-03 (71335073803)

Pricing Information	N/A
NDC Package Code	71335-0738-3
Billing NDC	71335073803
Package	60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0738-3)
Marketing Start Date	2016-07-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c70857b5-4d4d-44b4-8955-ada6a74a0356 Details

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

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 stool softener 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 (1-800-222-1222).

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

Tamper Evident: do not use if safety seal under cap is broken or missing
each capsule contains: sodium 6 mg
VERY LOW SODIUM
store at 25°C (77°F); excursions permitted between 15o-30oC (59o-86oF).

Keep tightly closed.

This Package for Households Without Young Children

Inactive ingredients

D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

Adverse drug event call: (800) 687-0176 Mon- Fri 8 AM to 4 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

HOW SUPPLIED

Product: 71335-0738

NDC: 71335-0738-0 50 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-2 100 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-3 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-4 120 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-5 90 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-6 180 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-7 10 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-8 28 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0738-9 56 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 100mg Capsule

INGREDIENTS AND APPEARANCE

STOOL SOFTNER

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0738(NDC:66424-399)
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 RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (Two toned- white and clear red)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0738-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
2	NDC:71335-0738-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
3	NDC:71335-0738-7	10 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
4	NDC:71335-0738-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
5	NDC:71335-0738-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
6	NDC:71335-0738-8	28 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
7	NDC:71335-0738-9	56 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
8	NDC:71335-0738-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
9	NDC:71335-0738-0	50 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016
10	NDC:71335-0738-6	180 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/01/2016

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0738) , RELABEL(71335-0738)

Revised: 1/2020

Document Id: 2ef0bb0f-6168-4d4c-9ede-d940b5afbe4b

Set id: c70857b5-4d4d-44b4-8955-ada6a74a0356

Version: 3

Effective Time: 20200119