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stool softener by Central Texas Community Health Centers

Medically reviewed on October 31, 2016

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Central Texas Community Health Centers
NDC Code: 76413-324

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.

Drug Facts

Active ingredient (in each softgel)

Docusate calcium 240 mg

Purpose

Stool softener laxative

Uses
  • 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.

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. 
  • you need to use a laxative for more than 1 week

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 of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information
  • store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6*, gelatin, glycerin, purified water, sorbitol special

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL - 240 MG Capsule Bottle Label

CommUnityCare Federally Qualified Health Centers

DOCUSATE
CALCIUM
240 MG
CAPS

Date:

Name:
Dr.

TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.

123456

1/1/01

DOCUSATE CA.240MG CAPS#30NDC 76413-324-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

STOOL SOFTENER 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-324(NDC:49348-122)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN, UNSPECIFIED 
GLYCERIN 
WATER 
SORBITOL 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeP20;SCU
Contains    
Packaging
#Item CodePackage Description
1NDC:76413-324-3030 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/30/2014
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-324), RELABEL(76413-324)

 
Central Texas Community Health Centers

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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