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  5. Label Information: Senna-s Laxative With Stool Softener

FDA Label for Senna-s Laxative With Stool Softener

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senna-s Laxative With Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Basic Drugs, 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.

Active Ingredient (In Each Tablet)



Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg


Uses



  • relieves ocasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours.

Warnings



Do not use

  • if you are 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 a period of 2 weeks

      • Stop use and ask a doctor if

      • you have rectal bleeding
      • you 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.


Directions



  • take only by mouth
  • 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 maximum dosage) or decrease dose until you are comfortable.

    • agestarting dosagemaximum dosage
    adults and children 12 years of age and over2 tablets once a day

    4 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 tablet twice a day
    children under 2 years of ageask a doctorask a doctor


Other Information



  • each tablet contains: calcium 6mg, sodium 3mg
  • store between 15° - 30°C (59° - 86°F)

Inactive Ingredients



Croscarmellose sodium, D&C Yellow #10, dicalcium phosphate, FD&C Yellow # 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide


Questions?



937-898-4010


Package Label.Principal Display Panel




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