Your browser does not support JavaScript! STOOL SOFTENER GENTLE (DOCUSATE SODIUM) CAPSULE [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]
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RxNorm Names

STOOL SOFTENER GENTLE (docusate sodium) capsule
[Good Sense (Geiss, Destin & Dunn, Inc.)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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.

Directions

  • take with a glass of water
 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

  • 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 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50804-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-005-251 in 1 BOX
125 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33408/24/2010
Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
 
Good Sense (Geiss, Destin & Dunn, Inc.)

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