Label: FLEET- enema enema

  • NDC Code(s): 0132-0119-46
  • 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 29, 2017

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  • 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 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 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

  • If pregnant or breast-feeding

    Ask a health professional before use.

  • 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.

  • 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 years 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 118-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
    • 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 the Reference Safety Information on our website
  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Fleet Enema Six Pack Carton

  • INGREDIENTS AND APPEARANCE
    FLEET 
    enema enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0119
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 133 mL
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC7 g  in 133 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0119-46133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/26/2011
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0119)
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