STOOL SOFTENER LAXATIVE- docusate calcium capsule, liquid filled

Stool Softener Laxative by

Drug Labeling and Warnings

Stool Softener Laxative by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate calcium 240 ​mg

Purpose

Stool softener laxative

Uses

• for relief of occasional constipation (irregularity) 
• 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.

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

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 over: take 1 softgel daily or as directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

corn oil, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-800-616-2471

Principal Display Panel

Compare to the active ingredient in Surfak®†

Docusate Calcium

240 mg

Stool Softener Laxative

Sodium Free

Softgels

†This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Product Label

MAJOR Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6997
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	SCU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6997-60	1 in 1 BOX	09/30/2019
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0904-6997-40	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2019
3	NDC: 0904-6997-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	09/30/2019

Labeler - Major Pharmaceuticals (191427277)