Docusate Sodium
FDA Label NDC 54868-6209

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Docusate Sodium (NDC 54868-6209). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each teaspoon), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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, 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)

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

* Please review the disclaimer below.