STOOL SOFTENER- docusate calcium capsule, liquid filled

stool softener by

Drug Labeling and Warnings

stool softener by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-324(NDC:49348-122)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Inactive Ingredients
Ingredient Name	Strength
CORN OIL (UNII: 8470G57WFM)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P20;SCU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-324-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	05/30/2014

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-324) , RELABEL(76413-324)