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  5. Label Information: Docusate Sodium

FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 MG (600 CAPSULES CONTAINER LABEL)

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Sam's West 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 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 or in divided doses.


adults and children 12 years and over
take 1-3 softgel 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 5 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F). Keep tightly closed.

Inactive Ingredients



D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.


Questions Or Comments?



Call 1-855-274-4122 (toll-free)

(Monday - Friday 8:30 AM to 5:00 PM EST)


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


DISTRIBUTED BY
SAM'S WEST, INC.
BENTONVILLE, AR 72716


Package Label-Principal Display Panel - 100 Mg (600 Capsules Container Label)



Compare to Colace®
active ingredient*

NDC 68196-995-64


Member's Mark™

Stool
Softener

Docusate sodium 100 mg

Regular Strength

* Please review the disclaimer below.