Your browser does not support JavaScript! STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE [MCKESSON (SUNMARK)]
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RxNorm Names

STOOL SOFTENER (docusate sodium) capsule
[Mckesson (Sunmark)]


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 right away: 1-800-222-1222

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 - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

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

Principal Display Panel

†Compare to Dulcolax® Stool Softener active ingredient

STOOL SOFTENER

DOCUSATE SODIUM 100 mg

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

Another quality product distributed by McKesson

one post street, San Francisco, CA 94104

Money back gurantee

Please visit us at www.sunmarkbrand.com

Questions or comments? Call toll free 1-877-753-3935

Product Label

 sunmark stool softener 25 count

docusate sodium 100 mg

STOOL SOFTENER 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-917
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 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-917-051 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 - Mckesson (Sunmark) (177667227)

Revised: 09/2012
Document Id: 4f0877a3-431e-4fd2-b006-c232cc5ca3a2
Set id: 469ddb7a-dacc-4901-afc7-69d32b1889d4
Version: 1
Effective Time: 20120925
 
Mckesson (Sunmark)

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