STOOL SOFTENER- docusate sodium capsule, liquid filled 
SMART SENSE (Kmart)

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

  • temporary relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

  • if abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

  • you notice a sudden change in bowel habits that persists over a period of 2 weeks
  • you are presently taking mineral oil

Stop use and ask a doctor if

  • rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition
  • you need to use a laxative for more than 1 week

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 immediately (1-800-222-1222).

Directions

  • take with a glass of water
 adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years of age  ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

Call toll free 1-800-842-7886

Principal Display Panel

Compare to the active ingredient of Dulcolax® Stool Softener*

CONSTIPATION RELIEF

Stool Softener

Docusate Sodium, 100 mg

Gentle, Dependable Relief of Occasional Constipation

SOFTGELS**

(**Liquid Filled Capsules)

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax® Stool Softener. 

Distributed by: Kmart Corporation, Hoffman Estates, IL  60179  Shop Kmart.com

Product of USA

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label

Docusate Sodium 100 mg

Smart Sense Stool Softener Orange Softgel

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-500
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 (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-500-18180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201312/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/30/201312/31/2020
Labeler - SMART SENSE (Kmart) (008965873)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: 8e1d93e0-64db-44a5-af86-809e34f63346
Set id: b2da9ea4-0b8d-4d7f-8f69-3ac97df4e869
Version: 2
Effective Time: 20181226
 
SMART SENSE (Kmart)