Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fleet
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
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.
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 |
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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 30 mL delivered**dose)**
OTC - PURPOSE SECTION
Purpose
Bisacodyl 10 mg .............Stimulant laxative/ bowel cleanser
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.
SPL UNCLASSIFIED SECTION
Drug Facts
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