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)
Monobasic Sodium Phosphate 19 g, Saline Laxative
Dibasic Sodium Phosphate 7 g, Saline LaxativeClose
For relief of occasional constipation.Close
For rectal use only.
Using more than one enema in 24 hours can be harmful.
Do not use without asking a doctor:
- for more than 3 days
- if you have kidney disease
- if you have heart problems
- if you are dehydrated
- Ask a doctor before using this product if you
- are 55 years of age or older
- are on a sodium-restricted diet
Ask a doctor before using any laxative if you have
- abdominal pain, nausea, or vomiting
- 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 or urinating less often than normal)
These symptoms may indicate a serious condition.Close
- If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.Close
- Keep out of reach of children
Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.Close
Single Daily Dosage (per 24 hours).
Do not use more unless directed by a doctor. See Warnings.
Do not use if taking another sodium phosphates product
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
- Other information
- 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
benzalkonium chloride, disodium EDTA, purified waterClose
1-866-255-6960 or www.fleetlabs.comClose
- 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)