Bisacodyl
FDA Label NDC 50730-1004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H And P Industries, Inc. Dba Triad Group for the product Bisacodyl (NDC 50730-1004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

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
Children 6 to 12 years
Children under 6
One suppository once
daily
1/2 suppository once
daily
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

CVS pharmacy

NDC 50730-1004-0
Compare to the active
ingredient in Dulcolax®
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Gentle
LAXATIVE
SUPPOSITORIES
Bisacodyl USP


GUARANTEED RELIEF
Gentle Yet Effective

4 Suppositories (10mg each)

Comfort Shaped

Distributed by CVS Pharmacy, Inc. One CVS Drive
Woonsocket, RI 02895 ©CVS/pharmacy
www.cvs.com  1-800-shop-CVS

This product is not manufactured or distributed by Boehringer Ingelhem
Consumer Healthcare, owner of the registered trademark Dulcolax®.

Box (33 1004cvs C A0109)

Box (33 1004cvs C A0109)

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