DOCUSATE CALCIUM capsule, liquid filled

Docusate calcium by

Drug Labeling and Warnings

Docusate calcium by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers, P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Calcium 240 mg

Purpose

Stool softener

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
• when abdominal pain, nausea, or vomiting are present
• for longer than 1 week, unless directed by a doctor

Ask a doctor before use 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 s 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 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
• children under 12 years of age: take as directed by a doctor

Other information

• store between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special.

Questions or comments?

1-800-645-2158

Principal Display Panel

Compare to active ingredient in SURFAK®*

Safe, Effective, Non-Habit Forming

Stool Softener Laxative DC

Docusate Calcium USP, 240 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 Surfak®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

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: 76413-307-30

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

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

INGREDIENTS AND APPEARANCE

DOCUSATE CALCIUM 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-307(NDC: 0536-3755)
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (RED)	Score	no score
Shape	OVAL (OVAL)	Size	8mm
Flavor		Imprint Code	P58
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-307-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/01/2011

Labeler - Central Texas Community Health Centers (079674019)

Registrant - P and L Development of New York Corporation (800014821)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-307) , RELABEL(76413-307)