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  5. Label Information: Docusate Sodium

FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PDP

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals 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.

Other



Drug Facts


Active Ingredient (In Each Softgel)



Docusate Sodium 100 mg 


Purpose



Stool Softner


Uses



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

Warnings



Warnings


Ask A Doctor Before Use If You Have



  • stomach pain, nausea or vomittiong
  • a sudden change in bowel habits that lasts more than 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 laxative for more than 1 week.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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


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

    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



  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive Ingredients



FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.


Questions Or Comments?



1-888-333-9792


Pdp



Cabinet:
Stool Softener
Docusate Sodium 100mg

75 Softgels

image description - Docusate

image description - Docusate


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