STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled 
Cardinal Health

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 sodium 250 mg

Extra Strength

Stimulant-Free

Relief of Constipation

Purpose

Stool softener laxative

Uses

•
for the prevention of dry, hard stools
•
for relief of occasional constipation
•
this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are presently 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 breast-feeding,

ask a health professional before use.

This package is intended for institutional use only.

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

•
each softgel contains: sodium 15 mg
•
store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients​

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

*may contain this ingredient

Questions or comments?

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

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Rugby is a trademark owned by its respective owner.

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L50978290815

LUP50978290715

Principal Display Panel

Stool Softener

Docusate sodium 250mg

Extra Strength

10 Softgels

bag label

Principal Display Panel

Stool Softener

(docusate sodium)

softgel

250 mg

pouch
STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6817(NDC:0536-1064)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P20;SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6817-010 in 1 BAG01/31/201503/31/2018
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/31/201503/31/2018
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6817)

Revised: 3/2018
Document Id: d1db7fad-7546-4800-8860-2afd547e9797
Set id: a8a2a988-956f-44f1-8442-66743953b9ae
Version: 2
Effective Time: 20180331
 
Cardinal Health