Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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DOCUSATE SODIUM - docusate sodium capsule 
Aurohealth LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-767
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeOVALSize13mm
FlavorImprint Code Q04
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-767-64600 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/08/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-767)

Revised: 2/2018
 
Aurohealth LLC


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