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STOOL SOFTNER by Unit Dose Services

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Unit Dose Services
NDC Code: 50436-0399

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.

Drug Facts

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 agetake 1 softgel daily
children under 2 yearsask 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: 50436-0399

NDC: 50436-0399-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

STOOL SOFTNER (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED
STOOL SOFTNER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-0399(NDC:66424-399)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
Colorred (Two toned- white and clear red) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeSCU2
Contains    
Packaging
#Item CodePackage Description
1NDC:50436-0399-1 30 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2016
Labeler - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-0399), RELABEL(50436-0399)

 
Unit Dose Services

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Medically reviewed on Aug 28, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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