Stool Softener by Rugby Laboratories, Inc.

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Rugby Laboratories, Inc.
NDC code: 0536-1065

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Drug Facts

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

STOOL SOFTENER
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1065
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE CALCIUM (DOCUSATE)	DOCUSATE CALCIUM	240 mg

Inactive Ingredients
Ingredient Name	Strength
CORN OIL
D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
WATER
SORBITOL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
SORBITAN

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P58;SCU
Contains

Packaging
#	Item Code	Package Description
1	NDC:0536-1065-01	100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2	NDC:0536-1065-05	500 CAPSULE, LIQUID FILLED in 1 BOTTLE
3	NDC:0536-1065-10	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE

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)

Document Id: 7e365a36-b4be-4a75-b25c-8b08d4294d46

Set id: 30720723-fd35-422f-b5c3-2390a72fc608

Version: 6

Effective Time: 20200618

Rugby Laboratories, Inc.

See all Stool Softener brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer