STOOL SOFTENER- docusate calcium capsule, liquid filled 
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 Calcium 240 mg

Purpose

Stool softener

Uses

For relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

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.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breastfeeding

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

Other information

Inactive Ingredients

corn oil, D&C Red #33, edible white ink, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Stool softener

For gentle relief of constipation

DOCUSATE CALCIUM

Compare to Surfak® Active Ingredient*

Another quality product distributed by McKesson

one post street, San francisco, CA 94104

Money back gurantee

Please visit us at  www.sunmarkbrand.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Sunmark stool softener

Docusate calcium 240 mg

 

STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-280
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM 240 mg
Inactive Ingredients
Ingredient Name Strength
CORN OIL (UNII: 8470G57WFM)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code P58
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-280-10 1 in 1 BOX
1 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 07/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
Document Id: 05990ba5-4433-477e-9ab0-d740a13b6479
Set id: aefdabf5-3a81-400e-8e52-7d385fda12d6
Version: 1
Effective Time: 20120924
 
Mckesson (Sunmark)