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Stool Softener by Rugby Laboratories, Inc.

Medically reviewed on Nov 21, 2016

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-1065

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.

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

Rugby Stool Softener

 

STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1065
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
WATER 
SORBITOL 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
SORBITAN 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeP20;SCU
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1065-01100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:0536-1065-05500 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:0536-1065-101000 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/31/2015
Labeler - Rugby Laboratories, Inc. (079246066)

 
Rugby Laboratories, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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