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  5. Label Information: Stool Softener

FDA Label for Stool Softener

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Velocity Pharma. 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

Warnings



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

    • Ask a doctor or pharmacist before use if you are presently taking mineral oil.

    Stop use and ask a doctor if:

    • you have rectal bleeding or no bowel movement after using this product. This could be signs of a serious condition.
    • you need to use 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



Take with glass of water

adults and children 12 years and over:

  • 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

    Children under 12 years of age:

  • 1 liquid gel daily

    • Children under 2 years of age

    Ask a doctor


Other Information



  • store at 15-30 °C (59-86 °F)
  • protect from excessive humidity
  • do not use this product if the safety seal under the cap is torn or missing

Inactive Ingredients



FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide


Questions Or Comments



Call 1-855-314-1850


Package Label.Principal Display Panel



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NDC: 076168-069-05 – 25 COUNT


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