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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 GELCAPS)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU
    7. STOP USE ABD ASK A DOCTOR IF YOU
    8. IF PREGNANT OR BREAST-FEEDING
    9. STOP USE AND ASK A DOCTOR IF YOU
    10. IF PREGNANT OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL- VALUMEDS STOOL SOFTENER 100CAPGELS BOTTLE LABELS

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 Gelcaps)



Docusate Sodium 100 mg 


Purpose



Stool Softner


Uses



  • for the prevention of the dry, hard stools
  • for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours

Do Not Use



if you are currently taking mineral oil, unless directed to so by a doctor.

When abdominal pain, nausea, or vomiting are present for longer than 1 week unless directed by a doctor


Ask A Doctor Before Use If You



notice a sudden change in bowel habits that persists over a period of 2 weeks


Stop Use Abd Ask A Doctor If You



have rectal bleeding fail to have a bowel movement occur after use.


If Pregnant Or Breast-Feeding



ask a health professional before use

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.


Stop Use And Ask A Doctor If You



have rectal bleeding fail to have bowel movement occur after use.


If Pregnant Or Breast Feeding



Ask a health professional before use 


Keep Out Of Reach Of Children



In case of accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.


Directions



  • adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime
    • children 2 to under 12 years of age: take 1 gelcap at bedtime
    • children under 2 years of age: ask a doctor

Other Information



  • Store at room temperature 15-30°C  (59-86°F) 
  • do not use if safety seal under cap is torn or missing

Inactive Ingredients



FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

glycerin, polyethylene glycol 400, propylene glycol, purified

water, shellac, sorbitol solution, titanium dioxide.


Questions Or Comments?



1-888-333-9792


Principal Display Panel- Valumeds Stool Softener 100Capgels Bottle Labels



VALUMEDS

Compare to the active ingredient in

Colace ® Gel Caps *

STOOL

SOFTENER

DOCUSATE SODIUM 100 mg

  • Gentle
  • Effective
  • Stimulant-Free Relief

    • 100 GELCAPS


* Please review the disclaimer below.