EXTRA STRENGTH STOOL SOFTENER LAXATIVE- 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

Purpose

Stool softener

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 currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for more than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use

These could be signs of a serious condition.

If pregnant or breast-feeding,

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.

This package is intended for in-patient institutional use only.

Directions

adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor
children under 12 years of age: take as directed by a doctor

Other information

each softgel contains: sodium 15 mg

store between 15º-30ºC (59º-86ºF)
See window for lot number and expiration date

Inactive Ingredients

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

Questions or comments?

1-800-645-2158

Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250 mg

SOFTGEL CAPSULES

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150
www.rugbylaboratories.com

Rugby is trademark of its respective owner.

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC4600029-10114

LUC4600029-20114

Principal Display Panel

Stool Softener

(docusate sodium USP)

250 mg

pouch

Principal Display Panel

Stool Softener

(docusate sodium USP)

250 mg

100 Softgel Capsules

Bag Label

Principal Display Panel

Stool Softener

Laxative

Docusate Sodium USP, 250 mg

10 SOFTGEL CAPSULES

Bag Label

 

EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-6812(NDC:0536-3757)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color orange (orange) Score no score
Shape OVAL (OVAL) Size 20mm
Flavor Imprint Code P20
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-6812-4 100 in 1 CARTON
1 NDC:55154-6812-6 1 in 1 POUCH; Type 0: Not a Combination Product
2 NDC:55154-6812-0 10 in 1 BAG
2 1 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/29/2012
Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-6812)

Revised: 9/2014
Document Id: 44c81163-4cdc-4399-9dd0-3e5febf987fc
Set id: 5a8af826-858c-4f98-b059-4a71d320dd0b
Version: 5
Effective Time: 20140910
 
Cardinal Health