EXTRA STRENGTH STOOL SOFTENER LAXATIVE - docusate sodium capsule, liquid filled 
Rugby Laboratories, Inc.

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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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.

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

Stool Softener

EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 GLYCOL 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
Colororange (orange) Scoreno score
ShapeOVAL (OVAL) Size20mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3757-01100 in 1 BOTTLE
2NDC:0536-3757-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/29/2012
Labeler - Rugby Laboratories, Inc. (109178264)

Revised: 04/2012
Document Id: 35040ba3-5787-43b8-a497-7e64c7fc0a22
Set id: 18300b1c-71ff-4021-a5e6-c859ce4498c1
Version: 7
Effective Time: 20120411
 
Rugby Laboratories, Inc.