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.

Drug Label Information

Updated August 22, 2017

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each 197-mL delivered dose)

    Monobasic Sodium Phosphate 19 g, Saline Laxative

    Dibasic Sodium Phosphate 7 g, Saline Laxative

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  • Use

    For relief of occasional constipation.

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  • Warnings

    For rectal use only.


    Dosage warning:

    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
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  • 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
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  • 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.

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  • If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

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  • 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.

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  • Directions

    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

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  • 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
    BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE. Close
  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

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  • Questions?

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

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  • INGREDIENTS AND APPEARANCE
    FLEET 
    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)
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