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.

PRINCIPAL DISPLAY PANEL - 240 mg Capsule Bottle Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

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

Docusate calcium