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NDC 00536-1065-01 Stool Softener 240 mg/1 Details

Stool Softener 240 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is DOCUSATE CALCIUM.

MedlinePlus Drug Summary

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 00536-1065-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	00536-1065
Product ID	0536-1065_85bad6d2-5e32-470d-9f58-7285b90c454e
Associated GPIs	46500010100105
GCN Sequence Number	003005
GCN Sequence Number Description	docusate calcium CAPSULE 240 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09061
HICL Sequence Number	001324
HICL Sequence Number Description	DOCUSATE CALCIUM
Brand/Generic	Brand
Proprietary Name	Stool Softener
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate calcium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	240
Active Ingredient Units	mg/1
Substance Name	DOCUSATE CALCIUM
Labeler Name	Rugby Laboratories, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 00536-1065-01 (00536106501)

Pricing Information	N/A
NDC Package Code	0536-1065-01
Billing NDC	00536106501
Package	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1065-01)
Marketing Start Date	2015-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 30720723-fd35-422f-b5c3-2390a72fc608 Details

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

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 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	P58;SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1065-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2015	02/23/2024
2	NDC:0536-1065-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2015	02/23/2024
3	NDC:0536-1065-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2015	02/23/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/31/2015	02/23/2024

Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 11/2021

Document Id: 85bad6d2-5e32-470d-9f58-7285b90c454e

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

Version: 7

Effective Time: 20211101