DOCUSATE SODIUM STOOL SOFTENER- docusate sodium capsule, liquid filled 
Robinson Pharma, Inc.

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 Stool Softener

Docusate Sodium Stool Softener


Active Ingredient (in each softgel)

Docusate Sodium 50 mg

Purpose

Stool softener laxative

Uses

  • relieves occasional constipation and 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 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 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

  • Take only by mouth. Doses may be taken as a single does or in divided doses.

adults and children 12 years and over
take 1-6 softgels
Children 2 to under 12 years of age
take 1-3 softgels
Children under 2 years
ask a doctor

Other Information

  • store at  25 degrees C (77 degrees F); excursions permitted between 15 degrees - 30 degrees C (59 degrees - 86 degrees F).
  • Protect from excessive humidity
  • each softgel contains : sodium 3 mg

VERY LOW SODIUM

Keep tightly closed.

Inactive Ingredients

FD C Red No. 40, FD C Yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, peppermint oil, edible ink.

Questions?

8am-5pm PST, Mon-Fri

Docusate Sodium Stool Softener 50 mg 30 count (59995-003-00)


InnerLabel

OuterLabel

DOCUSATE SODIUM STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59995-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize13mm
FlavorImprint Code RP3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59995-003-0030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/201305/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/30/201305/30/2013
Labeler - Robinson Pharma, Inc. (831560578)
Registrant - Robinson Pharma, Inc. (831560578)

Revised: 1/2017
 
Robinson Pharma, Inc.