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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. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    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. PRINCIPAL DISPLAY PANEL - 50 SOFTGEL BOTTLE CARTON

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product J.p. Business Enterprise. 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

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755


Active Ingredient (In Each Softgel)



Docusate sodium 100 mg


Purpose



Stool softener


Uses



  • for prevention of dry, hard stools
  • for relief of occasional constipation

    • This product generally produces a bowel movement within 12 to 72 hours.


Otc - Do Not Use



Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor

Otc - Ask Doctor



Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.


Otc - Stop Use



Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

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.


Directions



  • take with a glass of water
    • adults and children 12 years of age and overtake 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 agetake 1 softgel daily
    children under 2 years of ageconsult a physician

Other Information



  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients



FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)


Questions Or Comments?



Call toll free: 1-888-333-9792


Principal Display Panel - 50 Softgel Bottle Carton



VALUMEDS

Compare to the active ingredient in
Dulcolax ® Stool Softener

STOOL SOFTENER
DOCUSATE SODIUM 100 MG

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