1. Home
  2. Labeler Index
  3. Spirit Pharmaceuticals Llc
  4. 68210-0317
  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. OTC - ASK DOCTOR/PHARMACIST
    8. STOP USE AND ASK A DOCTOR IF YOU
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL- VALUMEDS STOOL SOFTENER 30 SOFTELS BOTTLE LABELS-SINGLE TONE

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 laxative


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

Otc - Ask Doctor/Pharmacist



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


Stop Use And Ask A Doctor If You



  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo 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 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



  • Store at room temperature 20-25°C  (68-77°F) 
  • protect from excessive humidity
  • do not use this product of the safety seal under the cap is torn or missing

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


Principal Display Panel- Valumeds Stool Softener 30 Softels Bottle Labels-Single Tone



VALUMEDS TM

Compare to the active ingredient in

Dulcolax  ® Stool Softener  *

STOOL  SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief
Constipation Relief

30 SOFTGELS


* Please review the disclaimer below.