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  5. Label Information: Bisacodyl

FDA Label for Bisacodyl

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. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Bisacodyl Product Label

The following document was submitted to the FDA by the labeler of this product Padagis Us 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 Suppository)



Bisacodyl USP 10 mg


Purpose



Stimulant laxative


Use



  • •for temporary 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
  • •a sudden change in bowel habits that lasts more than 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


When Using This Product



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


Stop Use And Ask A Doctor If



  • •you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate 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.



If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



adults and children 12 years of age and over

1 suppository in a single daily dose. Pull apart foil. Insert suppository well 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



  • •store at 20-25°C (68-77°F)

Inactive Ingredients



hydrogenated vegetable oil


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



NDC 0574-7050-12

Bisacodyl Suppositories, USP

10 mg

Stimulant Laxative

Easy-open plastic packets

Tapered shape for easy insertion

UNIT DOSE

12 Suppositories


* Please review the disclaimer below.