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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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 121 to 7 teaspoons
    children 2 to under 121 to 3 teaspoons
    children under 2ask 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

Image of Container Label

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-771
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
METHYLPARABEN 
POLYETHYLENE GLYCOL 4000 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM BENZOATE 
SODIUM CITRATE 
WATER 
POLOXAMER 181 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorVANILLA (natural and artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50383-771-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/01/1997
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
 
Hi-Tech Pharmacal Co., Inc.