STOOL SOFTENER- docusate sodium capsule 
Mckesson (Sunmark)

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.

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Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

Warnings - Do not use

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

 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-917
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code P51
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-917-05 1 in 1 BOX
1 25 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 08/24/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
Document Id: 4f0877a3-431e-4fd2-b006-c232cc5ca3a2
Set id: 469ddb7a-dacc-4901-afc7-69d32b1889d4
Version: 1
Effective Time: 20120925
 
Mckesson (Sunmark)