Label: FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic enema

  • NDC Code(s): 0132-0201-40, 0132-0201-42, 0132-0201-45
  • 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 June 16, 2017

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

View All Sections
  • Active Ingredient (in each 118-mL delivered dose)

    Monobasic Sodium Phosphate 19 g.................Saline Laxative

    Dibasic Sodium Phosphate 7 g........................Saline Laxative

  • Use

    For relief of occasional constipation.

  • Warnings

    For rectal use only.

    Dosage warning: Using more then 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 consult 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.

  • 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.

  • If pregnant or breast-feeding

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

  • 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.

  • Other Information

    • each 118-mL delivered dose contains: sodium 4.4 g
    • additional liquids by mouth are recommended while taking this product
    • this product usually produces a bowel movement in 1-5 minutes
    • BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE
    • for complete professional use warnings and precautions, consult Reference Safety Information on our website
  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions?

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

  • Fleet Enema Principle Display Panel

    Fleet Enema Carton

  • INGREDIENTS AND APPEARANCE
    FLEET 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0201
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 133 mL
    sodium phosphate, monobasic (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) sodium phosphate, monobasic19 g  in 133 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0201-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
    2NDC:0132-0201-42133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
    3NDC:0132-0201-45133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/10/1953
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0201)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!