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  5. Label Information: Stool Softener

FDA Label for Stool Softener

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. STOP USE AND ASK A DOCTOR IF
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical Llc. 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 laxative


Uses



  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours

Ask A Doctor Before Use If You Have



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

Stop Use And Ask A Doctor If



  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



take with a glass of water

adults and children 12 years and over

     1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

children 2 to under 12 years of age

     1 softgel daily

children under 2 years of age

     ask a doctor


Other Information



  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive humidity

Inactive Ingredients



citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink


Questions Or Comments?



Call toll free: 1-800-833-6278


Principal Display Panel



STOOL SOFTENER 

DOCUSATE SODIUM 100mg  100 SOFTGELS

Compare to the active ingredient in DULCOLAX®

NDC 51013-120-24


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