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

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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

Docusate Sodium 100 mg

RUGBY Stool Softener

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51;S77;SCU1;D2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1062-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201509/28/2023
2NDC:0536-1062-29100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201512/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/31/201512/01/2023
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 11/2023
Document Id: 7ef5c97d-f85b-4531-a39b-4f65848687a6
Set id: 9ce2ad29-887c-4ce5-a2a0-e957f16b5d7c
Version: 10
Effective Time: 20231127
 
Rugby Laboratories, Inc.