Docusate sodium capsule

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 25C (77F); excursions permitted between 15-30C (59-86F). 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

Ingredients and appearance - Product information

Docusate sodium capsule- Docusate sodium

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-767
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Docusate sodium ( UNII: F05Q2T2JA0)( Docusate - UNII: M7P27195AG ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
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 Shape OVAL
Size 13 mm Score 1
Imprint Code Q04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part334 USA 2018/02/08

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-767)

Package label-principal display panel - 100 mg(600capsules 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