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.

----------

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

Principal Display Panel

Stool Softener

(docusate sodium USP)

250 mg

100 Softgel Capsules

Principal Display Panel

Stool Softener

Laxative

Docusate Sodium USP, 250 mg

10 SOFTGEL CAPSULES

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
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)

Product Characteristics
Color	orange (orange)	Score	no score
Shape	OVAL (OVAL)	Size	20mm
Flavor		Imprint Code	P20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-6812-4	100 in 1 CARTON	03/29/2012	09/30/2014
1	NDC:55154-6812-6	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:55154-6812-0	10 in 1 BAG	03/29/2012	03/31/2016
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/29/2012	03/31/2016

Labeler - Cardinal Health (603638201)

Revised: 5/2019

Document Id: 26539872-5059-45e7-b5a5-e8940bb7b20e

Set id: 5a8af826-858c-4f98-b059-4a71d320dd0b

Version: 6

Effective Time: 20190509

Cardinal Health