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  5. Label Information: Docusate Sodium

FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TEASPOON)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - 6209

Image of Container Label - 473 mL - 6209

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.