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  5. Label Information: Senna And Docusate Sodium

FDA Label for Senna And Docusate Sodium

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS AND USAGE
    4. WARNINGS
    5. OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - STOP USE AND ASK A DOCTOR IF
    7. OTC – IF PREGNANT OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE AND ADMINISTRATION
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT

Senna And Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Sunrise Pharmaceutical Inc. 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



Docusate sodium 50 mg

Sennosides 8.6 mg


Otc - Purpose



Stool softener and Stimulant laxative


Indications And Usage



  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12 hours

Warnings



Do not use:

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Otc - Ask A Doctor Before Use If You Have



  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over 2 weeks

Otc - Stop Use And Ask A Doctor If



You have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.


Otc – If Pregnant Or Breast Feeding



Ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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


Dosage And Administration



  • Take preferably at bedtime or as directed by a doctor
    • agestarting dosagemaximum dosage
    adults and children 12 years  of age or older2 tablets once a day4 tablets twice a day
    children 6 to under 12 years  1 tablet once a day2 tablets twice a day
    children 2 to under 6 years ½ tablet once a day1 tablet twice a day
    children under 2 years ask a doctorask a doctor

Other Information



  • Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM
  • Do not use if imprinted safety seal under cap is missing or damaged.
  • Store at 25° C (77° F); excursions permitted between 15° C-30° C (59° -86° F).
  • Keep tightly closed.

Inactive Ingredient



Colloidal silicon dioxide, dicalcium phosphate, D&C yellow No 10 Aluminum Lake, ethanol, FD&C yellow No 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, mineral oil,  polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide


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