Your browser does not support JavaScript! EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH]
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EXTRA STRENGTH STOOL SOFTENER LAXATIVE (docusate sodium) capsule, liquid filled
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-6812(NDC:0536-3757)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colororange (orange) Scoreno score
ShapeOVAL (OVAL) Size20mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6812-4100 in 1 CARTON
1NDC:55154-6812-61 in 1 POUCH
2NDC:55154-6812-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/29/2012
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6812)

Revised: 1/2014
 
Cardinal Health

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