DOCUSATE SODIUM- docusate sodium capsule 
Direct_Rx

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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DOCUSATE SODIUM


Docusate Sodium 100 mg


Stool softener laxative

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

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 last 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 a signs of a serious condition.
you need to use a 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.

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

each softgel contains: sodium 6 mg
store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients


Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

525-71

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-525(NDC:0904-6457)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
SORBITAN (UNII: 6O92ICV9RU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51;S77;SCU1;D2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-525-71100 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/19/2019
Labeler - Direct_Rx (079254320)
Registrant - Direct_Rx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
Direct_Rx079254320repack(61919-525)

Revised: 10/2022
Document Id: ea4ea1f6-6aa6-5b5d-e053-2a95a90a3ae1
Set id: 907c288b-def5-1b2b-e053-2a95a90ac0b9
Version: 2
Effective Time: 20221005
 
Direct_Rx