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  5. Label Information: Bisacodyl Laxative

FDA Label for Bisacodyl Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENT
    16. OTC - QUESTIONS
    17. PACKAGE INFORMATION

Bisacodyl Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. 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, 10 mg


Purpose



Stimulant Laxative


Uses



  • For relief of occasional constipation
  • This product generally produces bowel movement in 15 minutes to 1 hour

Warnings



For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.



Do Not Use



  • more than one per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if seal under product lid is torn, damaged, or open

Ask A Doctor Before Use



  • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby



Otc - Ask Doctor/Pharmacist





Otc - When Using





Stop Use And Ask A Doctor



If you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding





Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults and children 12 years of age and older
One suppository once daily
Children 6 to 12 years
1/2 suppository once daily
Children under 6
Ask a doctor
  • Detach one suppository from the strip and remove from foil
  • Carefully insert one suppository well into the rectum
  • Do not use more than once per day

Other





Other Information



  • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
  • Individually sealed for your protection. Do not use if foil is torn or open.

Inactive Ingredient



Hydrogenated vegetable oil

Otc - Questions





Package Information



Sunmark®

COMPARE TO DULCOLAX® ACTIVE INGREDIENT
NDC 49348-598-67

For prompt relief of constipation often in 15 minutes to 1 hour

Laxative
Suppositories

BISACODYL USP
CONSTIPATION RELIEF

8 SUPPOSITORIES 10 mg EACH

FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN PAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

*This product is not manufactured or distributed by Boehringer Ingelhem
Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.

Another Quality Product
Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
Please visit us at www.sunmarkbrand.com


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