Fleet
Fleet Bisacodyl Enema NDC 0132-0703-36
324e61eb-8f6b-48d7-85c2-b1b5642691c9
HUMAN OTC DRUG LABEL
Jun 23, 2025
C.B. Fleet Company, Inc.
DUNS: 003119054
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bisacodyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Fleet
Laxative
bisacodyl
Enema
INDICATIONS & USAGE SECTION
Uses
-
for relief of fecal impaction
-
for relief of occasional constipation
-
for removal of residue after barium administration
This product usually produces a bowel movement in 5 to 20 minutes.
OTC - PURPOSE SECTION
Purpose
Bisacodyl 10 mg .............Stimulant laxative/ bowel cleanser
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 30 mL delivered**dose)**
WARNINGS SECTION
Warnings
For rectal use only.
Do not use
when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask a doctor before using this product if you
-
have a sudden change in bowel habits lasting more than 2 weeks
-
already used a laxative for more than 1 week
This product may cause abdominal discomfort, faintness, rectal burning, and mild cramps.
Stop use and ask a doctor if you have
• rectal bleeding
• no bowel movement within 20 minutes of using this product.
These symptoms may indicate a serious condition.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
Single Daily Dosage (per 24 hours)
|
adults and children 12 years and over |
1 bottle per day |
|
children under 12 years |
DO NOT USE |
OTHER SAFETY INFORMATION
Other information
• store at temperatures not above 86˚ F (30˚ C)
INACTIVE INGREDIENT SECTION
Inactive ingredients
carbomer 934P, glycerin, methylparaben, octoxynol-9, propylparaben, purified water, sodium hydroxide
OTC - QUESTIONS SECTION
Questions?
or www.fleetlabs.com
**Tamper Evident:**bottle sealed for safety. If bottle wrapper with fleet emblem is torn, damaged or missing, do not use.