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STOOL SOFTENER by McKesson

Medically reviewed on October 13, 2016

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 100mg
Labeler: McKesson
NDC Code: 49348-167

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.

sun 421

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

  • have stomach pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of the 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 older: take 1-2 tablets daily until first bowel movement; 1 tablet daily thereafter, or as directed by doctor
  • children under 12: consult a doctor
  • do not exceed recommended dose

Other information
  • each tablet contains: calcium 50 mg, sodium 8 mg
  • for institutional use only
  • package not child resistant
  • store at room temperature 15°C-30°C (59°F-86°F)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, stearic acid, talc

PACKAGE LABEL

Sunmark

COMPARE TO COLACE®
ACTIVE INGREDIENT*

NDC 49348-167-10

Stool Softener

For relief of occasional constipation

Docusate Sodium 100 mg

100 Tablets

STOOL SOFTENER 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-167(NDC:75841-421)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
CROSCARMELLOSE SODIUM 
MICROCRYSTALLINE CELLULOSE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
TALC 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeGC422
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-167-101 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2016
Labeler - McKesson (177667227)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(49348-167), relabel(49348-167)

 
McKesson

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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