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Stool Softener by Rugby Laboratories, Inc.

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-1062

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 sodium 100mg

Purpose

Stool softener laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

 if you are presently taking  mineral oil, unles told to do so 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 a signs of a serious condition.
  • you need to use a laxative for more than 1 week

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.

Directions
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
 adults and children 12 years and over take 1-3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other information
  • each softgel contains: sodium 6 mg 
  • store at 25ºC (77F); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible ink, FD &C red #40, FD &C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

*may contains this ingredients

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Colace® Regular Strength Stool Softener**

Stool Softener

Docusate sodium 100mg

Stool Softener Laxative

Gentle

Effective

Stimulant-Free

Softgels

**This product is not manufactured or distributed by Purdue Product L.P., distributor of Colace® Regular Strength  Stool Softener.

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

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48150

www.rugbylaboratories.com

Product Labeling

RUGBY Stool Softener

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
MEDIUM-CHAIN TRIGLYCERIDES 
SORBITAN 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeP51;S77;SCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1062-101000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
2NDC:0536-1062-29100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
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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Medically reviewed on Feb 19, 2018

Further information

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

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