DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Direct_Rx

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DOCUSATE SODIUM

Docusate Sodium 100 mg

Purpose

Stool softener

for prevention of dry, hard stools
for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Do not use

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
children 6-12 years of age take 1 softgel at bedtime
children under 6 years ask a doctor

each softgel contains: sodium 6 mg
store between 15º-30ºC (59º-86ºF)


edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.


1-800-645-2158

459-60

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-459(NDC:0536-3756)
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
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colororange ((orange)) Scoreno score
ShapeOVAL ((OVAL)) Size13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-459-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/14/201910/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00708/14/201910/09/2023
Labeler - Direct_Rx (079254320)
Registrant - Direct_Rx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
Direct_Rx079254320repack(61919-459)

Revised: 10/2023
 
Direct_Rx