DOCUSATE SODIUM - docusate sodium capsule, liquid filled 
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient (in each softgel capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation
  • generally produces bowel movement in 12-72 hours

Warnings

Do not use

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

 

Ask a doctor before use if you have

noticed 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 have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate 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.

Directions

adults and children 12 years and over
1-3 capsules once daily or in a divided doses
children 6 to under 12 years
1 capsule once daily
children under 6 years
ask a doctor

Other information

  • each capsule contains: sodium 6 mg
  • store between 15°-30°C (59°-86°F)

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,
propylene glycol, purified water and sorbitol special.

Questions or comments?

Call 1-800-645.2158,  9 am - 5 pm ET, Monday-Friday

Do not use
  • If you are taking mineral oil
  • when abdominal pain, nausea, or vomiting are present
  • for longer than one week

Ask a doctor before use if you have a sudden change in bowel habits that last 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 have rectal bleeding
  • you fail to have a bowel movement after using this product
These may indicate 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.

PRINCIPAL DISPLAY PANEL - PACKAGE LABEL

Docusate Sodium / Stool Softener

100 mg - Red SGel Capsules

NDC 54868-0096-4

image of package label


*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark Colace.
Distributed by Rugby Laboratories, Inc.
Duluth, GA     30097


Additional bar code label by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146



DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0096(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 
POLYETHYLENE GLYCOL 4000 
PROPYLENE GLYCOL 
GELATIN 
GLYCERIN 
SORBITOL 
WATER 
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize1mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-0096-160 in 1 BOTTLE
2NDC:54868-0096-4100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/200701/15/2013
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-0096)

Revised: 02/2013
 
Physicians Total Care, Inc.