DOCU LIQUID- docusate sodium liquid

Docu Liquid by

Drug Labeling and Warnings

Docu Liquid by is a Otc medication manufactured, distributed, or labeled by Hi-Tech Pharmacal Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Keep Out of Reach of Children

Uses

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

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
• store in an upright position

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.

Package/Label Principal Display Panel

NDC: 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

TAMPER EVIDENT: FOR YOUR PROTECTION THE CHILD RESISTANT CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

NET CONTENTS ONE PINT (473 mL)

INGREDIENTS AND APPEARANCE

DOCU LIQUID 
docusate sodium liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
POLOXAMER 181 (UNII: 09Y8E6164A)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50383-771-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/1997
2	NDC: 50383-771-11	10 in 1 CASE	01/13/2010
2		10 in 1 TRAY
2	NDC: 50383-771-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

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)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(50383-771)