STOOL SOFTENER GENTLE- docusate sodium capsule 
Good Sense (Geiss, Destin & Dunn, 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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Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

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.

Directions

 adults and children 12 years of age 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

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

Gentle Stool Softener

Docusate Sodium

For Gentle, Softening Relief

Gluten Free

Softgels (100 mg Each) 

*Compare to active ingredient in Dulcolax® Stool Softener

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

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

Product of USA

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Docusate Sodium 100 mg

Good Sense Stool Softener Orange Softgel

STOOL SOFTENER  GENTLE
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-005
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code P51
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50804-005-25 1 in 1 BOX
1 25 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 08/24/2010
Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
Document Id: 4b3930b0-23ac-46ae-b171-1067a01a8b9a
Set id: 49aea7a4-3502-4348-8d8e-9c4c02b0d725
Version: 1
Effective Time: 20130419
 
Good Sense (Geiss, Destin & Dunn, Inc.)