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  5. Label Information: Colistat Plus

FDA Label for Colistat Plus

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSES
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL

Colistat Plus Product Label

The following document was submitted to the FDA by the labeler of this product Amvilab Llc. 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 Ingredients (In Each Tablet)



Docusate Sodium 50 mg

Sennosides 8.6 mg


Purposes



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

Sennosides.......................................Laxative


Uses



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

Do Not Use



  • if you are now 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
  • noticed a sudden change in bowel habits that continues over a period of 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 may indicate 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
    • agestarting dosemaximum dose
    adults and children 12 years and older
    		2 tablets once a day
    		4 tablets twice a day
    children 6 to under 12 years
    		1 tablet once a day
    		2 tablets twice a day
    children 2 to under 6 years
    		1/2 tablet once a day
    		1 tablet twice a day
    children under 2 years
    		ask a doctor
    		ask a doctor

Other Information



  • Each tablet contains: Calcium 20 mg
  • Each tablet contains: Sodium   4 mg
  • Store at room temperature
  • Keep lid tightly closed in a dry place
  • Do not use if imprinted seal under cap is broken or missing
  • Tamper Evident: Do not use if sealed blister unit is broken or damaged

Inactive Ingredients



Croscarmellose Sodium, D and C Yellow #10, Dextrose, Dicalcium Phosphate, FD and C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.


Questions?



If you have any questions or comments,or to report an adverse event, please contact +1 404 256 8817.


Principal Display Panel



COLISTAT PLUS

Stool Softener and Stimulant Laxative



* Please review the disclaimer below.