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NDC 58602-0767-64 DOCUSATE SODIUM 100 mg/1 Details

DOCUSATE SODIUM 100 mg/1

DOCUSATE SODIUM is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. 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: 58602-0767-64
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	58602-0767
Product ID	58602-767_5ae40894-9395-4cb5-af85-f2015c1f25f0
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	DOCUSATE SODIUM
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCUSATE SODIUM
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Aurohealth LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 58602-0767-64 (58602076764)

Pricing Information	N/A
NDC Package Code	58602-767-64
Billing NDC	58602076764
Package	600 CAPSULE in 1 BOTTLE (58602-767-64)
Marketing Start Date	2018-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 85e8d319-5921-48b6-9235-f16b52ab50d2 Details

Active ingredient

(in each Capsule)

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 (1-800-222-1222) 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 capsules daily
children 2 to under 12 years of age	take 1 capsule daily
children under 2 years	ask a doctor

Other information

each capsule contains: sodium 5 mg Very Low Sodium
store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.

Inactive ingredients

D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

Questions or Comments?

Call 1-855-274-4122

(Monday - Friday 8:30 AM to 5:00 PM EST)

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

Distributed by:

Aurohealth LLC.

2572 Brunswick Pike

Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

AUROHEALTH

NDC 58602-767-64

Compare to Colace®

active ingredient*

Stool Softener

Docusate sodium 100 mg

Regular Strength

Gentle, Dependable
Stimulant-free

600 Capsules

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-767
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)
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	Q04
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-767-64	600 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2018
2	NDC:58602-767-14	50 in 1 CARTON	02/08/2018
2		50 in 1 BOTTLE; 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	02/08/2018

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	MANUFACTURE(58602-767)

Revised: 12/2020

Document Id: 5ae40894-9395-4cb5-af85-f2015c1f25f0

Set id: 85e8d319-5921-48b6-9235-f16b52ab50d2

Version: 3

Effective Time: 20201204