DOCU- docusate sodium liquid 
Hi-Tech Pharmacal Co., Inc.

Disclaimer: 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.

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Drug Facts

Active ingredient (in each teaspoon)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Use

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

Other information

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?

 

REV. 771:06 02/13

PRINCIPAL DISPLAY PANEL

Docu liquid_label_16 oz

NDC 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

  

TAMPER EVIDENT: CAP SEALED WITH BREAKAWAY BAND AROUND BOTTLE NECK DO NOT ACCEPT IF BROKEN OR MISSING

 

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 (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 4000 (UNII: 4R4HFI6D95)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
POLOXAMER 181 (UNII: 09Y8E6164A)  
Product Characteristics
Color PINK Score     
Shape Size
Flavor VANILLA (natural and artificial vanilla 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
2 NDC:50383-771-11 10 in 1 CASE
2 10 in 1 TRAY
2 NDC:50383-771-10 10 mL in 1 CUP, UNIT-DOSE
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: 11/2013
Document Id: 54865ec1-0308-4717-a6a0-3536d84d7bc2
Set id: 7fdc4368-4888-4792-86d3-c8a828e4fff2
Version: 4
Effective Time: 20131112
 
Hi-Tech Pharmacal Co., Inc.