FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic enema

Fleet by

Drug Labeling and Warnings

Fleet by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Purpose

(in each 197 mL delivered dose)

Monobasic sodium phosphate 19g ... Saline laxative

Dibasic sodium phosphate 7g ......... Saline laxative

Use

for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.

Warnings

For rectal use only.

Using more than one enema in 24 hours can be harmful.

Do not use

for more than 3 days

if you have kidney disease

if you have heart problems

if you are dehydrated

when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor before using this product if you

are 55 years of age or older

are on a sodium-restricted diet

have 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, 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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Single Daily Dosage (per 24 hours).

Do not use if taking another sodium phosphates product. Do not use more unless directed by a

doctor. See Warnings.

• 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

If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other information

each 197 mL delivered dose contains: sodium 4.4 g

additional liquids by mouth are recommended while taking this product

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

PRINCIPAL DISPLAY PANEL

Fleet
Laxative
Saline
Enema
Extra Volume
1 Bottle 7.8 Fl Oz (230 mL) each

INGREDIENTS AND APPEARANCE

FLEET 
sodium phosphate, dibasic and sodium phosphate, monobasic enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0078
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0078-01	230 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/25/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	06/25/2004

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