Label: READY-TO-USE ENEMA- sodium phosphate enema

  • 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 23, 2012

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  • Active ingredient (in each 118 mL delivered dose)

    Sodium Phosphate 19 g

    Dibasic Sodium Phosphate 7 g

  • Purpose

    saline laxative & bowel cleanser

  • Use

     for relief of occasional constipation or bowel cleansing before rectal examinations

  • Warnings

    For rectal use only

    Dosage warning: Using more than one enema in 24 hours can be harmful

    Ask a doctor before using this product if you:

    • Are on a sodium-restricted diet
    • Have kidney disease

    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 after the enema is given

    These symptoms may indicate a serious condition

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • When using this product, do not use more than directed.

    Serious side effects may occur from excess dosage.

  • Directions

    One dose daily. Do not use more unless directed by a doctor. See Warnings.

    adults & children 12 years and older1 Bottle
    children under 12 yearsAsk your child's pediatrician
    children under 2 yearsDO NOT USE
  • Other Information

    • Each 118 mL contains: sodium 4.4 g
    • This product generally results in a bowel movement in 1 to 5 minutes
    • Tamper Evident: If the bottle is open do not use
    • Consult PHYSICIAN DESK REFERENCE® for complete professional labeling.
  • Inactive Ingredients

    Benzalkonium chloride, disodium EDTA and purified water

  • Questions or comments?

    Call 1-877-545-3635

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  • INGREDIENTS AND APPEARANCE
    READY-TO-USE ENEMA 
    sodium phosphate enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-222
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC7 g  in 118 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:11673-222-022 in 1 CARTON
    1133 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/23/2012
    Labeler - Target Corporation (006961700)
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