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  5. Label Information: Colistat

FDA Label for Colistat

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    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 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 Ingredient (In Each Tablet)



Docusate Sodium 100 mg


Purpose



Stool Softener


Uses



  • for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.

Do Not Use



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

Ask A Doctor Before Use If You Have



  • stomach pain
  • nausea
  • vomiting
  • noticed  a sudden change in bowel habits that lasts over 2 weeks

Stop Use And Ask A Doctor If



  • you have rectal bleeding
  • you fail to have a bowel movement after use

    • These could be signs of a serious condition.



If Pregnant Or Breast-Feeding,



ask a doctor before use.


Keep Out Of Reach Of Children.



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


Directions



Adults and
children 12 years of age and older:		Take 1 tablet as needed,
not to exceed more than 3
tablets daily, or as directed
by a doctor.
Children under
12 years of age:		Consult a doctor before use.







Other Information



  • Each tablet contains: Calcium 40 mg
  • Each tablet contains: Sodium 10  mg
  • Store at room temperature.
  • Do not use if imprinted safety seal is broken or missing

Inactive Ingredients



Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.


Questions?



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


Principal Display Panel



COLISTAT

Docusate Sodium

Stool Softener



* Please review the disclaimer below.