FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic enema 
C.B. Fleet Company, Inc.

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Fleet Saline Enema 0132-0201

Active Ingredient (in each 118 mL delivered dose)

Monobasic Sodium Phosphate 19 g................

Dibasic Sodium Phosphate 7 g........................

Purpose

Saline laxative

Saline laxative

Use

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

Warnings

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

For rectal use only.

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 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 years and over     1 bottle per day
children 2 to 11 yearsuse Fleet® Pedia-Lax® Enema
children under 2 yearsDO 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

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

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

Tamper Evident: Do not use if imprinted seal on bottom flap or top flap is broken or missing.

PRINCIPAL DISPLAY PANEL

Fleet ®
Laxative
Saline Enema
1 Bottle 4.5 Fl Oz (133 mL)

Fleet ®
Laxative 
Saline Enema 
1 Bottle 4.5 Fl Oz (133 mL)

FLEET 
sodium phosphate, dibasic and sodium phosphate, monobasic enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0201
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0201-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
2NDC:0132-0201-42133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
3NDC:0132-0201-45133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00703/10/1953
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 12/2024
Document Id: 70d17be3-25df-46e2-9b3a-36ca0632b5bb
Set id: c1677d70-203b-493e-88f0-815a66133f1d
Version: 11
Effective Time: 20241219
 
C.B. Fleet Company, Inc.