RxNorm Names

Review RxNorm Normal Forms

DOCU (docusate sodium) liquid
[Hi-Tech Pharmacal Co., Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7fdc4368-4888-4792-86d3-c8a828e4fff2

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 teaspoon)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Use

relieves occasional constipation
generally produces bowel movement in 12-72 hours

Warnings

Do not use

if you are presently taking mineral oil
when abdominal pain, nausea, or vomiting are present
for longer than one week

Ask a doctor before use if you have

noticed a sudden change in bowel habits that lasts over two weeks.

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use of this product

These may indicate a serious condition.

If pregnant or breast-feeding,

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

may be taken once daily or in divided doses
give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation
adults and children over 12 1 to 7 teaspoons

children 2 to under 12 1 to 3 teaspoons

children under 2 ask a doctor

Other information

each teaspoon contains: sodium 5 mg
shake well before using
store at controlled room temperature 15° - 30°C (59° - 86°F)
dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP.

Inactive ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

Questions or comments?

Call 1-800-262-9010
Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

REV. 771:05 08/12

PRINCIPAL DISPLAY PANEL

NDC 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

TAMPER EVIDENT: FOR YOUR PROTECTION, THIS BOTTLE HAS A SAFETY SEAL AROUND THE NECK OR UNDER THE CAP.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

NET CONTENTS ONE PINT (473 mL)

DOCU
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50383-771
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	50 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33
METHYLPARABEN
POLYETHYLENE GLYCOL 4000
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM BENZOATE
SODIUM CITRATE
WATER
POLOXAMER 181

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	VANILLA (natural and artificial vanilla flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:50383-771-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/01/1997

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 12/2012

Document Id: 240aa054-3abc-4983-a21e-0c2a7f6ae6d2

Set id: 7fdc4368-4888-4792-86d3-c8a828e4fff2

Version: 3

Effective Time: 20121213