FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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

Do Not Use



if you are currently taking mineral oil, unless directed by a doctor


Ask A Doctor Before Use If You Have



  • •stomach pain, nausea or vomiting
  • •have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop Use And Ask A Doctor If



  • •you have rectal bleeding
  • •you fail to have a bowel movement after use
  • •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 overdose, get medical help or contact a Poison Control Center right away.


Directions



  • •doses may be taken as a single daily dose or in divided doses
  • adults and children 12 years and over                        

    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



  • •each capsule contains sodium 6 mg
  • •store at room temperature 15o-30oC (59o-86oF)
  • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Questions?



Adverse drug event call (800) 687-0176


Principal Display Panel



Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320


* Please review the disclaimer below.