DOCUSATE SODIUM - docusate sodium  capsule, liquid filled 
Unit Dose Services

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 softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

Warnings


Do not use

if you are currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • 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.

Directions

adults and children 12 years and over                        
take 1 to 3 softgels daily
children 2 to under 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor

Other information

Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special


Questions?

Adverse drug event call (800) 687-0176

HOW SUPPLIED

Product: 50436-1222

NDC: 50436-1222-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED

Label Image
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-1222(NDC:66424-030)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color red (Two toned- white and clear red) Score no score
Shape OVAL Size 5mm
Flavor Imprint Code 51A
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-1222-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 09/15/2010
Labeler - Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Business Operations
Unit Dose Services 831995316 REPACK(50436-1222) , RELABEL(50436-1222)

Revised: 12/2016
Document Id: b947c887-4900-452b-bff2-d2044f9d403d
Set id: 33586efa-a589-49d7-8913-9d4503bfbe1f
Version: 4
Effective Time: 20161208
 
Unit Dose Services