DOCUSATE CALCIUM capsule

Docusate Calcium by

Drug Labeling and Warnings

Docusate Calcium by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Calcium 240mg

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

If pregnant or breastfeeding

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 at controlled room temperature 15º - 30ºC (59º - 86ºF)

-*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak® Stool Softener.

Inactive ingredients

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

Questions?

Adverse Drug Event Call: (800) 616-2471

Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150, USA

Principal Display Panel

Docusate Calcium Softgel Capsules

240mg

INGREDIENTS AND APPEARANCE

DOCUSATE CALCIUM 
docusate calcium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-0378(NDC:0904-5779)
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	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P58
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-0378-39	30 in 1 BLISTER PACK

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

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-0378) , REPACK(0615-0378)