RxNorm Names

Review RxNorm Normal Forms

DOCUSATE SODIUM capsule, liquid filled
[NCS HealthCare of KY, Inc dba Vangard Labs]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7cdecfb2-e09a-4b48-b9d6-00045518825e

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active Ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

for the prevention of dry, hard stools
for relief of occasional constipation.

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
when abdominal pain, nausea or vomiting are present
for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use

If pregnant or breastfeeding

ask a health care 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 over 12 years of age: take 1 to 3 softgels preferably at bedtime
children 6- 12 years of age: take 1 softgel at bedtime

Other information

each softgel contains: sodium 6mg
store at controlled room temperature 15o - 30o C (59o- 86o F)
*This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Adverse Drug Event Call: (800)-616-2471)

Distributed by : Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

Principal Display Panel

Principal Display Panel-Docusate Sodium 100mg

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-0585(NDC:0904-7889)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SORBITOL

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-0585-05	15 in 1 BLISTER PACK
2	NDC:0615-0585-31	31 in 1 BLISTER PACK
3	NDC:0615-0585-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	04/23/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-0585), REPACK(0615-0585)

Revised: 02/2013

Document Id: 3154b168-1ad8-4dbf-a615-63458f17cc4c

Set id: 7cdecfb2-e09a-4b48-b9d6-00045518825e

Version: 6

Effective Time: 20130227

NCS HealthCare of KY, Inc dba Vangard Labs

Daily Med

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