Label: GADAVYT ENEMA- dibasic sodium phosphate, monobasic sodium phosphate liquid

  • 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 October 31, 2012

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients (in each 118 mL delivered dose)

    Dibasic sodium phosphate 7 g............. Saline Laxative

    Monobasic sodium phosphate 19 g......... Saline Laxative

  • PURPOSE

    Uses
    • relieves occasional constipation
  • WARNINGS

    Warnings

    For rectal use only

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



    Ask a doctor before use if you have
    • a sodium-restricted diet
    • abdominal pain, nausea or vomiting
    • kidney disease, heart problems, or are dehydrated
    • noticed a sudden change in bowel habits that lasts over 2 weeks
    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    When using this product
    • do not use more than directed. Serious side effects may occur from excess dosage.
    • do not use for more than 3 days


  • DO NOT USE

    Stop use and ask a doctor if
    • you have rectal bleeding
    • you have no bowel movement after use of a laxative

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

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



    adults and children 12 years and over
    		one bottle once daily
    children 2 to under 12 years
    		1/2 bottle once daily
    children under 2 years
    		do not use
  • INDICATIONS & USAGE

    Other information
    • each 118 mL contains: sodium 4.3 g
    • store at room temperature 20-25 degrees C (68 -77 degrees F)
    • this product generally produces bowel movement in 1 to 5 minutes
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • QUESTIONS

    Questions or comments?

    305-382-3288

  • PRINCIPAL DISPLAY PANEL

    enemaadults

  • INGREDIENTS AND APPEARANCE
    GADAVYT ENEMA 
    dibasic sodium phosphate, monobasic sodium phosphate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-104
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 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:53113-104-45133 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2012
    Labeler - Gadal Laboratories Inc (841305639)
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!