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  5. Label Information: Docusate Sodium

FDA Label for Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT SECTION
    2. OTC - PURPOSE SECTION
    3. INDICATIONS & USAGE SECTION
    4. OTC - DO NOT USE SECTION
    5. OTC - ASK DOCTOR SECTION
    6. OTC - STOP USE SECTION
    7. OTC - PREGNANCY OR BREAST FEEDING SECTION
    8. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    9. DOSAGE & ADMINISTRATION SECTION
    10. OTHER SAFETY INFORMATION
    11. INACTIVE INGREDIENT SECTION
    12. OTHER
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Direct Rx. 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.

Otc - Active Ingredient Section



Docusate sodium 100 mg


Otc - Purpose Section



Stool softener


Indications & Usage Section




relieves occasional constipation (irregularity)  
generally produces bowel movement in 12 to 72 hours


Otc - Do Not Use Section



Do not use if you are presently taking mineral oil, unless told to do so by a doctor


Otc - Ask Doctor Section




stomach pain  
nausea  
vomiting  
noticed a sudden change in bowel habits that lasts over 2 weeks


Otc - Stop Use Section




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 a laxative for more than 1 week


Otc - Pregnancy Or Breast Feeding Section



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


Otc - Keep Out Of Reach Of Children Section



In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration Section



doses may be taken as a single daily dose or in divided doses


Other Safety Information



each softgel contains: sodium 5 mg VERY LOW SODIUM  
store at 15°-30°C (59°-86°F)  
keep tightly closed

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.


Inactive Ingredient Section



FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special


Other



Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0 07/2011
015021CPR


Package Label.Principal Display Panel



image description - Label

image description - Label


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