STOOL SOFTENER- docusate calcium capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Calcium 240mg

Purpose

 Stool softener laxative

Uses

• for relief of occasional constipation.
• this product generally produces a bowel movement within 12 to72 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 breastfeeding

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

Inactive Ingredients

corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C Red #40, FD&C yellow ≠≠6*, gelatin, glycerin, purified water and sorbitol special.

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Surfax®**

Stool Softener

Docusate calcium 240mg

Gentle Relief of Constipation

Take Once a Day

Softgels

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

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233 

Livonia, MI 48152

www.rugbylaboratories.com

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

Product Label

Rugby Stool Softener

 

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1065
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P20;SCU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1065-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2015
2	NDC: 0536-1065-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2015
3	NDC: 0536-1065-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/31/2015

Labeler - Rugby Laboratories, Inc. (079246066)