Label: FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic enema
- NDC Code(s): 0132-0078-01
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 29, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
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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
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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
- Inactive ingredients
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Questions?
1-866-255-6960 or www.fleetlabs.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEET
sodium phosphate, dibasic and sodium phosphate, monobasic enemaProduct 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)