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  5. Label Information: Docusate Sodium And Senna

FDA Label for Docusate Sodium And Senna

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT SECTION
    2. OTC - PURPOSE SECTION
    3. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    4. INDICATIONS & USAGE SECTION
    5. WARNINGS SECTION
    6. OTC - DO NOT USE SECTION
    7. OTC - ASK DOCTOR SECTION
    8. OTC - ASK DOCTOR/PHARMACIST SECTION
    9. OTC - STOP USE SECTION
    10. OTC - PREGNANCY OR BREAST FEEDING SECTION
    11. DOSAGE & ADMINISTRATION SECTION
    12. STORAGE AND HANDLING SECTION
    13. INACTIVE INGREDIENT SECTION
    14. OTC - QUESTIONS SECTION
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium And Senna 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



Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg


Otc - Purpose Section



Purposes
Stool Softener
Stimulant Laxative


Otc - Keep Out Of Reach Of Children Section



 KEEP OUT OF REACH OF CHILDREN SECTION


Indications & Usage Section



Uses

  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

Warnings Section



Warnings


Otc - Do Not Use Section



Do not use

  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea or vomiting are present

Otc - Ask Doctor Section



Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks


Otc - Ask Doctor/Pharmacist Section



Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


Otc - Stop Use Section



Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product.

    • These may indicate a serious condition.


Otc - Pregnancy Or Breast Feeding Section



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


Dosage & Administration Section



Directions
adults and children 12 years and over: 2-4 tablets once daily or in divided doses
children 6 to under 12 years: 1-2 tablets once daily or in divided doses
children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
children under 2 years: ask a doctor


Storage And Handling Section



Other information
each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
store at 20°-25°C (68°-77°F)


Inactive Ingredient Section



Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide


Otc - Questions Section



Questions or comments?
call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday


Package Label.Principal Display Panel



image description - docusatesod518

image description - docusatesod518


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