STOOL SOFTENER- docusate calcium capsule, liquid filled 
Rugby Laboratories, Inc.

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 240mg

Purpose

 Stool softener laxative

Uses

  • for relief of occasional constipation.
  • this product generally produces a bowel movement within 12 to72 hours.

Warnings

Do not use

if  you are currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

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

If pregnant or breastfeeding

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 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor.

Other information

  • store between 20º-25ºC (68º-77ºF);excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C Red #40, FD&C yellow ≠≠6*, gelatin, glycerin, purified water and sorbitol special.

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Surfax®**

Stool Softener

Docusate calcium 240mg

Gentle Relief of Constipation

Take Once a Day

Softgels

**This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233 

Livonia, MI 48152

www.rugbylaboratories.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Label

Docusate Calcium 240 mg

Rugby Stool Softener

 

STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1065
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P58;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1065-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/31/201502/23/2024
2NDC:0536-1065-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/31/201502/23/2024
3NDC:0536-1065-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/31/201502/23/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/31/201502/23/2024
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 11/2021
Document Id: 85bad6d2-5e32-470d-9f58-7285b90c454e
Set id: 30720723-fd35-422f-b5c3-2390a72fc608
Version: 7
Effective Time: 20211101
 
Rugby Laboratories, Inc.