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NDC 00132-0201-10 Fleet 7; 19 g/230mL; g/230mL Details

Fleet 7; 19 g/230mL; g/230mL

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, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC.

Product Information

NDC	00132-0201
Product ID	0132-0201_b574e93a-5c0b-4eaa-b8ce-2e5ffc539afe
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	sodium phosphate, dibasic and sodium phosphate, monobasic
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	7; 19
Active Ingredient Units	g/230mL; g/230mL
Substance Name	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC
Labeler Name	C.B. Fleet Company, Inc.
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00132-0201-10 (00132020110)

Pricing Information	N/A
NDC Package Code	0132-0201-10
Billing NDC	00132020110
Package	230 mL in 1 BOTTLE, WITH APPLICATOR (0132-0201-10)
Marketing Start Date	2004-06-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL db7520d8-9364-4d7a-ba81-79a2fc2fa40e Details

Active Ingredient (in each 197-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 of age 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

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 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 197-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
for complete professional use warnings and precautions, consult 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

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEET

sodium phosphate, dibasic and sodium phosphate, monobasic enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0201
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	7 g in 230 mL
sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	sodium phosphate, monobasic	19 g in 230 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0132-0201-10	230 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/25/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/25/2004

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

Name	Address	ID/FEI	Business Operations
Establishment
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0201)

Revised: 8/2017

Document Id: b574e93a-5c0b-4eaa-b8ce-2e5ffc539afe

Set id: db7520d8-9364-4d7a-ba81-79a2fc2fa40e

Version: 9

Effective Time: 20170822