DOCUSATE CALCIUM- stool softener capsule, liquid filled

Docusate Calcium by

Drug Labeling and Warnings

Docusate Calcium by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Calcium 240 mg

Purpose

Stool Softener Laxative

Uses

• relieves occasional constipation (irregularity)
• generally 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 physician
• children under 12: consult a doctor
• do not exceed recommended dose

Other information

• store at room temperature, 15°-30°C (59°-86°F)
• Package not child resistant
• Product of USA, Romania or Canada

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.

package Label

HEALTH STAR

THE SENSIBLE CHOICE FOR PRICE AND HEALTH

NDC: 57896-424-01

Docusate Calcium

Stool Softener

100 softgels

240 mg each

Compare to active ingredient in surfak*

INGREDIENTS AND APPEARANCE

DOCUSATE CALCIUM 
stool softener capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-424
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
MANNITOL (UNII: 3OWL53L36A)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CORN OIL (UNII: 8470G57WFM)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-424-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2000

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)