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NDC 00132-0703-36 Fleet 10 mg/30mL Details

Fleet 10 mg/30mL

Fleet is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by C.B. Fleet Company, Inc.. The primary component is BISACODYL.

MedlinePlus Drug Summary

Rectal bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 00132-0703-36
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl Rectal

Product Information

NDC	00132-0703
Product ID	0132-0703_36be417e-8635-49a0-930e-12d1d4b86dcf
Associated GPIs	46200010005110
GCN Sequence Number	023908
GCN Sequence Number Description	bisacodyl ENEMA 10MG/30ML RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	08734
HICL Sequence Number	001301
HICL Sequence Number Description	BISACODYL
Brand/Generic	Brand
Proprietary Name	Fleet
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bisacodyl
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	10
Active Ingredient Units	mg/30mL
Substance Name	BISACODYL
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0703-36 (00132070336)

Pricing Information
NDC Package Code	0132-0703-36
Billing NDC	00132070336
Package	37 mL in 1 BOTTLE, WITH APPLICATOR (0132-0703-36)
Marketing Start Date	2002-05-10
NDC Exclude Flag	N
Price Per Unit	0.05978
Pricing Unit	ML
Effective Date	2023-09-20
NDC Description	FLEET BISACODYL 10 MG ENEMA
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	2, 5
Classification for Rate Setting	B
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 324e61eb-8f6b-48d7-85c2-b1b5642691c9 Details

Active Ingredient (in each 30-mL delivered dose)

Bisacodyl 10 mg, Stimulant Laxative / Bowel Cleanser

Use

Use for relief of occasional constipation or bowel cleansing before rectal examinations

Warnings

For rectal use only

This product may cause abdominal discomfort, faintness, rectal burning, and mild cramps

Ask a doctor before using any laxative if you have

abdominal pain, nausea, or vomiting
a sudden change in bowel habits lasting more than 2 weeks
already used a laxative for more than 1 week

Stop use and ask a doctor if you have

rectal bleeding
no bowel movement within 20 minutes of enema use

These symptoms may indicate a serious condition.

Keep out of reach of children

Keept out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

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 information

this product generally produces a bowel movement in 5-20 minutes
store at temperatures not above 86F (30C)
For complete professional use warnings and precautions, consult the Reference Safety Information on our website
BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE

Inactive ingredients

carbomer 934P, glycerin, methylparaben, octoxynol-9, propylparaben, purified water, sodium hydroxide

Questions?

1-866-255-6960 or www.fleetlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEET

bisacodyl enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0703
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0703-36	37 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/10/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/10/2002

Labeler - C.B. Fleet Company, Inc. (003119054)

Name	Address	ID/FEI	Business Operations
Establishment
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0703)

Revised: 9/2017

Document Id: 36be417e-8635-49a0-930e-12d1d4b86dcf

Set id: 324e61eb-8f6b-48d7-85c2-b1b5642691c9

Version: 4

Effective Time: 20170928