Skip to Content

← See all STOOL SOFTENER brands

STOOL SOFTENER by Care One (American Sales Company)

Medically reviewed on December 27, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Care One (American Sales Company)
NDC Code: 41520-115

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.

Drug Facts

Active Ingredient (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses
  • for the prevention of dry, hard stools
  • for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use
  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea or vomiting are present
  • for longer than one week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowel movement after use

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 right away.

Directions
  • adults and children 12 years and over: take 1- 2 capsules preferably at bedtime
  • children 6 to 12 years of age: take 1 capsule at bedtime

Other information
  • each capsule contains: sodium 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water.

Principal Display Panel

Compare to active ingredient of COLACE®*

stool softener

Docusate sodium 100 mg

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

Product Label

Docusate Sodium 100 mg

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-115
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 
SORBITOL 
D&C RED NO. 33 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
WATER 
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint CodeP10;51A
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-115-251 BOTTLE (1 BOTTLE) in 1 BOX
125 CAPSULE, LIQUID FILLED (25 CAPSULE) in 1 BOTTLE
2NDC:41520-115-10100 CAPSULE, LIQUID FILLED (100 CAPSULE) in 1 BOTTLE
3NDC:41520-115-20250 CAPSULE, LIQUID FILLED (250 CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/20/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

 
Care One (American Sales Company)

← See all STOOL SOFTENER brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide