NON-HABIT FORMING STOOL SOFTENER- 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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Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

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 longer than 1 week, unless directed by a doctor 

Ask a doctor before use if

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 care 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 of age take 1 to 3 softgels preferably at bedtime
 children 6-12 years of age take 1 softgel at bedtime
 children under 6 years ask a doctor

Other information

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

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN COLACE®*

NON-HABIT FORMING

Stool Softener Laxative

Docusate Sodium USP, 100 mg

SOFTGEL CAPSULES

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Label

Docusate Sodium 100 mg

Rugby Stool Softener Laxative Softgel

NON-HABIT FORMING STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-3756
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 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) Size13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3756-01100 in 1 BOTTLE
2NDC:0536-3756-101000 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 (191427277)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
Document Id: ab17427e-4079-4c76-91f9-53af9b508b7e
Set id: 9a593cb1-d99b-47e1-8675-dc37caa024e9
Version: 4
Effective Time: 20130424
 
Rugby Laboratories Inc