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NDC 00132-0119-46 Fleet 7; 19 g/133mL; g/133mL Details

Fleet 7; 19 g/133mL; g/133mL

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 SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC.

Product Information

NDC	00132-0119
Product ID	0132-0119_5d796181-8d4f-4fb3-b0d2-89352cd9e282
Associated GPIs	46109902105100
GCN Sequence Number	003029
GCN Sequence Number Description	sodium phosphate,mono-dibasic ENEMA 19G-7G/118 RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	66559
HICL Sequence Number	001330
HICL Sequence Number Description	SODIUM PHOSPHATE,MONOBASIC/SODIUM PHOSPHATE,DIBASIC
Brand/Generic	Brand
Proprietary Name	Fleet
Proprietary Name Suffix	n/a
Non-Proprietary Name	Enema
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	7; 19
Active Ingredient Units	g/133mL; g/133mL
Substance Name	SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA],
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0119-46 (00132011946)

Pricing Information	N/A
NDC Package Code	0132-0119-46
Billing NDC	00132011946
Package	133 mL in 1 BOTTLE, WITH APPLICATOR (0132-0119-46)
Marketing Start Date	2011-05-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a2155d4e-ab12-4bce-80d1-47e31195a060 Details

Active Ingredient (in each 118-mL delivered dose)

Monobasic Sodium Phosphate 19 g, Saline Laxative

Dibasic Sodium Phosphate 7 g, Saline Laxative

Use

For relief of occasional constipation

Warnings

For rectal use only.

Dosage warning:

Using more than one enema in 24 hours can be harmful. Do not use without asking a doctor:

for more than 3 days
if you have kidney disease
if you have heart problems
if you are dehydrated

Ask a doctor before using this product if you

are 55 years or older
are on a sodium-restricted diet

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 or no liquid comes out of the rectum after 30 minutes
symptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal)

These symptoms may indicate a serious condition

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children

Keep 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).

Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphates product.

adults and children 12 years and over	1 bottle per day
children 2 to 11 years	Use Fleet Pedia-Lax Enema
children under 2 years	DO NOT USE

Other Information

each 118-mL delivered dose contains: sodium 4.4 g
additional liquids by mouth are recommended while taking this product
this product generally produces a bowel movement in 1-5 minutes
BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE.
for complete professional use warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEET

enema enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0119
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC	19 g in 133 mL
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC	7 g in 133 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0119-46	133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/26/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/26/2011

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

Name	Address	ID/FEI	Business Operations
Establishment
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0119)

Revised: 8/2017

Document Id: 5d796181-8d4f-4fb3-b0d2-89352cd9e282

Set id: a2155d4e-ab12-4bce-80d1-47e31195a060

Version: 4

Effective Time: 20170829