DOK- docusate sodium capsule 
A-S Medication Solutions

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 laxative

Uses

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 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.

Directions

adults and children 12 years and overtake 1 to 3 softgels daily.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information

Inactive ingredients

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

Questions or comments?

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

HOW SUPPLIED

Product: 50090-5268

NDC: 50090-5268-0 20 CAPSULE in a BOTTLE

NDC: 50090-5268-1 100 CAPSULE in a BOTTLE

NDC: 50090-5268-2 60 CAPSULE in a BOTTLE

DOK (DOCUSATE SODIUM) CAPSULE

Label Image
DOK 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5268(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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SORBITAN (UNII: 6O92ICV9RU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51;S77;SCU1;D2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-5268-020 in 1 BOTTLE; Type 0: Not a Combination Product10/19/2020
2NDC:50090-5268-260 in 1 BOTTLE; Type 0: Not a Combination Product10/19/2020
3NDC:50090-5268-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/28/2015
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-5268) , REPACK(50090-5268)

Revised: 3/2021
Document Id: 8370c638-6e86-4269-8372-686f146ea827
Set id: e5d7f7e7-c091-4546-9076-7672b1b7b7a8
Version: 5
Effective Time: 20210308
 
A-S Medication Solutions