Active ingredient (in each teaspoon)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses

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, planifoline, 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. 771:04 07/10

PRINCIPAL DISPLAY PANEL

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

NDC 54868-6209-0

NET CONTENTS ONE PINT (473 mL)

Image of Container Label - 473 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

Additional bar code labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

DOCUSATE SODIUM
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-6209(NDC:50383-771)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
VANILLA (UNII: Q74T35078H)
WATER (UNII: 059QF0KO0R)
POLOXAMER 181 (UNII: 09Y8E6164A)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54868-6209-0	473 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/07/2010

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel

adults and children over 12	1 to 7 teaspoons
children 2 to under 12	1 to 3 teaspoons
children under 2	ask a doctor

Drug Facts