RxNorm Names

Review RxNorm Normal Forms

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

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a753c56b-17c0-4451-9d4f-ba359de3af22

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 250mg

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 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 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 and over: take 1 softgel daily or as directed by a doctor

• children under 12 years of age: take as directed by a doctor

Other information

• each softgel contains: sodium 15mg

• store at controlled room temperature 15° - 30° C (59° - 86° F)

• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

Questions or comments?

ADVERSE DRUG EVENT CALL: (800) 616-2471

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Principal Display Panel

Docusate Sodium Softgel Caps 250mg

DOCUSATE SODIUM
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-0586(NDC:0904-7891)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
AMMONIUM LAURETH-5 SULFATE
1-PROPOXY-2-PROPANOL
WATER
SORBITOL

Product Characteristics
Color	RED (Orange)	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P20
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-0586-39	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	07/01/2010

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(0615-0586), REPACK(0615-0586)

Revised: 02/2013

Document Id: 5323026e-6102-42aa-88b7-fb3b2572bada

Set id: a753c56b-17c0-4451-9d4f-ba359de3af22

Version: 9

Effective Time: 20130225

NCS HealthCare of KY, Inc dba Vangard Labs

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