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  5. Label Information: Stool Softener Docusate Sodium

FDA Label for Stool Softener Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    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?
    14. PACKAGE LABELING:

Stool Softener Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Magno-humphries, 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 Softgel)



Docusate sodium 100 mg


Purpose



Stool softener


Uses



  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

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 
  • vomiting 
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop Use And Ask A Doctor If



  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions



  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
    •  adults and children 12 years of age and older take 1 to 3  softgels daily
     children 2 to under 12 years of age take 1 softgel daily
     children under 2 years ask a doctor


Other Information



  • ach softgel contains: sodium 7mg 
  • store at 15° to 30°C (59° to 86°F)
  • protect from moisture

Inactive Ingredients



FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special


Questions?



call toll-free 1-800-935-6737


Package Labeling:



Label13 - Label13

Label13 - Label13


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