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
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated August 22, 2017
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- 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)