Your browser does not support JavaScript! STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]
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STOOL SOFTENER EXTRA STRENGTH (docusate sodium) capsule, liquid filled
[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 250 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 taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for more than 1 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 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 over 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: take as directed by a doctor

Other information

  • each softgel contains: sodium 15 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 white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Stool Softener

Extra strength

Relieves constipation

Docusate sodium 250 mg

Another quality product distributed by McKesson

one post street

San Francisco CA 94104

Money back gurantee

Please visit us at www.sunmarkbrand.com

Product Label

Sunmark stool softener extra strength

Docusate Sodium 250 mg

 

STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-714
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 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
ShapeCAPSULESize20mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-714-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 09/2012
Document Id: 49cdb4b9-d20c-49ab-8348-fb4b373253ca
Set id: 79ec5b55-ff08-47e8-b8d8-08e32bfdc934
Version: 1
Effective Time: 20120925
 
Mckesson (Sunmark)

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