FDA Label for Sennosides And Docusate Sodium

View Indications, Usage & Precautions

Sennosides And Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson Packaging Services A Business Unit Of Mckesson Corporation. 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.

Active Ingredient



Docusate Sodium 50mg

Sennosides 8.6 mg


Purpose



Docusate Sodium...............Stool Softener

Sennosides.........................Stimulant Laxative


Uses



  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Do Not Use



  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have



  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel movements that persists over 2 weeks

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.
  • If pregnant or breast -feeding, ask a health professional before use.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Directions



  • Take preferably at bedtime or as directed by a doctor
  • If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.
  • AgeStarting DoseMaximum Dose
    Adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
    Children 6 to under 12 years1 tablet once a day2 tablets twice a day
    Children 2 to under 6 years1/2 tablet once a day1 tablets twice a day
    Children under 2 yearsask a doctorask a doctor

Other Information



  • each tablet contains calcium 20mg, sodium 6mg (LOW SODIUM)
  • store at 25°C (77°F)

Inactive Ingredients



carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide, **tapioca starch, **tartaric acid

** may contain one or more of these ingredients


* Please review the disclaimer below.