Label: FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic enema
- NDC Code(s): 0132-0201-10
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 22, 2017
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- Official Label (Printer Friendly)
- Active Ingredient (in each 197-mL delivered dose)
- Ask a doctor before using this product if you
- Stop use and ask a doctor if you have
- If pregnant or breast-feeding
- Keep out of reach of children
- 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
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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 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:0132-0201-10 230 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 not final part334 06/25/2004 Labeler - C.B. Fleet Company, Inc. (003119054) Establishment Name Address ID/FEI Business Operations C.B. Fleet Company, Inc. 003119054 manufacture(0132-0201)