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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Rugby Extra Strength Stool Softener Laxative

Active Ingredient (in each softgel)

Docusate Sodium 250mg

Purpose

Stool softener

Uses

  • Relieves occasional constipation.
  • Generally produces bowel movement within 12 to72 hours.

Warnings - Do not use

  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you experience rectal bleeding
  • you fail to have a bowel movement after using this product

These may indicate a serious condition.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

This package is inteded for in-patient institutional use only. This package is not chld resistant.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children over 12 years and over:1 capsule once daily
  • children under 12 years: ask a doctor

Other information

  • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 15mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Questions or comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Product Labeling

Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC4600029-10612

LUC4600029-20612

Principal Display Panel

Stool Softener

(docusate sodium USP)

250 mg

Pouch label

Principal Display Panel

Stool Softener

(docusate sodium USP)

250 mg

100 Softgel Capsules

Carton label

Principal Display Panel

Stool Softener

Laxative

Docusate Sodium USP, 250 mg

10 SOFTGEL CAPSULES

Carton 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: 3/2013
Document Id: 5a8af826-858c-4f98-b059-4a71d320dd0b
Set id: 5a8af826-858c-4f98-b059-4a71d320dd0b
Version: 1
Effective Time: 20130321
 
Cardinal Health