Bisacodyl Laxative
FDA Label NDC 49348-598

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Bisacodyl Laxative (NDC 49348-598). 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 (in each suppository), 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.

Label Section Quick Index

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
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