DOCUSATE CALCIUM- docusate calcium capsule, liquid filled
Cardinal Health

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.

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Docusate Calcium

Active ingredient (in each softgel)

Docusate Calcium 240 mg

Purpose

Stool Softener Laxative

Uses

• relieves occasional constipation (irregularity)

• general produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you
• have stomach pain, nausea, or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

•are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement.

These could be signs of a serious condition.

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 older: take 1 softgel daily, or as recommended by your physican
•: children under 12years: ask a doctor
•: do not exceed recommended dose

Other information

• store at room temperature, 15°-30°C (59°-86°F)

• This package is intended for in-patient institutional use only. This package is not child resistant

• Product from USA, Romania or Canada

• See window for lot number and expiration date

Inactive ingredients

Corn Oil, FD & C blue #1, FD & C Red #40, FD & C Yellow #6, Gelatin, Glycerin, Sorbitol Special, Water. May also contain D & C Red #33

COMPARE TO ACTIVE INGREDIENT IN SURFAK

*This product is not manufactured or distributed by the owner of the registered trademark SURFAK.

Dist. By: GERI-CARE PHARMACEUTICALS CORP.

1650 63rd Street

Brooklyn, NY 11204

HEALTH STAR

THE SENSIBLE CHOICE FOR PRICE AND HEALTH

Repackaged by:

Cardinal Health

Zanesville, OH 43701

L4334207-10916A

L4334207-20916A

Package/Label Principal Display Panel

Docusate Calcium Softgel

240 mg

Principal Display Panel

Docusate Calcium

240 mg

100 Softgels

Principal Display Panel

Docusate Calcium

240 mg each

10 softgels

DOCUSATE CALCIUM
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-1875(NDC:57896-424)
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 BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
MANNITOL (UNII: 3OWL53L36A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL (Capsule)	Size	18mm
Flavor		Imprint Code	SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-1875-4	100 in 1 CARTON	06/01/2011	03/31/2015
1	NDC:55154-1875-6	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:55154-1875-0	10 in 1 BAG	06/01/2011	02/28/2018
2	NDC:55154-1875-6	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/01/2011	02/28/2018

Labeler - Cardinal Health (188557102)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-1875)

Revised: 6/2017

Document Id: 8eea56da-05db-4bfa-9ac6-861a6263e4cd

Set id: 94441a20-2b1e-4f0b-8394-4dd7262381be

Version: 10

Effective Time: 20170615

Cardinal Health