1. Home
  2. Labeler Index
  3. Dolgencorp, Inc.
  4. 55910-223
  5. Label Information: Docusate Sodium

FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

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

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, 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.

Other



Drug Facts


Active Ingredient (In Each Softgel)



Docusate Sodium 100 mg 


Purpose



Stool Softner 


Uses



  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings



Warnings


Do Not Use



  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask A Doctor Before Use If You Have



  • stomach pain
  •  nausea
  • vomittiong
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop Use And Ask A Doctor If



  • you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition.
  • yo need to use a stool softener laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding,ask a health professional before use


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222


Directions



Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

Adults and children 12 years and over : take 1-3 softgels daily.

Children 2 to under 12 years of age :  take 1 softgel daily.

Children under 2 years of age: ask a doctor


Other Information



  • Store at 25°C  (77°F), excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed.

Inactive Ingredients



gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.


Questions Or Comments?



1-888-309-9030


Principal Display Panel



DGTM Health

Compare to the active ingredient of Colace®*

STOOL SOFTENER CLEAR

DOCUSATE SODIUM 100 mg

Relieves constipation

Gentle Relief

Stimulant-Free
Dye-Free

100 Softgels

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.


* Please review the disclaimer below.