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  5. Label Information: Dulcolax Laxative

FDA Label for Dulcolax Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL

Dulcolax Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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 Suppository)



Bisacodyl (USP) 10 mg


Purpose



Stimulant laxative


Use



  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

Warnings



For rectal use only


Ask A Doctor Before Use If You Have



  • stomach pain, nausea or vomiting  
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product



it may cause stomach discomfort, faintness, rectal burning and mild cramps  


Stop Use And Ask A Doctor If



  • you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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



adults and children 12 years of age and over       1 suppository in a single daily dose. Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age                         ½ suppository in a single daily dose

children under 6 years of age                               ask a doctor


Other Information



  • do not use if individual blister unit is open or torn
  • store at 20°-25°C (68°-77°F)  

Inactive Ingredient



hard fat


Questions?



Call 1-866-844-2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.


Principal Display Panel



Dulcolax
Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative
MEDICATED LAXATIVE SUPPOSITORY
4
COMFORT SHAPED
SUPPOSITORIES
DO NOT SWALLOW

PRINCIPAL DISPLAY PANELDulcolaxBisacodyl (USP) 10 mg Suppository/ Stimulant LaxativeMEDICATED LAXATIVE SUPPOSITORY4COMFORT SHAPEDSUPPOSITORIESDO NOT SWALLOW - dulcolax medicated laxative suppository 01

PRINCIPAL DISPLAY PANELDulcolaxBisacodyl (USP) 10 mg Suppository/ Stimulant LaxativeMEDICATED LAXATIVE SUPPOSITORY4COMFORT SHAPEDSUPPOSITORIESDO NOT SWALLOW - dulcolax medicated laxative suppository 01


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