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

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  • ACTIVE INGREDIENT

    Active ingredients (in each 59 mL delivered dose)

    Dibasic sodium phosphate 3.5 g............. Saline Laxative

    Monobasic sodium phosphate 9.5 g......... Saline Laxative

  • PURPOSE

    Uses

    for relief of 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 using this product if the child
    • is on a sodium-restricted diet
    • has kidney disease
    Ask a doctor before using any laxative if the child has
    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits that lasting more than 2 weeks
    • already used a laxative for more than 1 week
  • DO NOT USE

    Stop use and ask a doctor if the child has
    • rectal bleeding
    • no bowel movement within 30 minutes of enema use
    • symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)
    These symptoms may indicate 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

    Single Daily Dosage

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

    Do not use if child is taking another sodium phosphates product.

    children 5 to 11
    		one bottle as directed by a doctor
    children 2 to under 5 years
    		one-half bottle (see below)
    children under 2 years
    		DO NOT USE
    One-half bottle preparation:Unscrew cap and remove 2 table spoons of liquid with a measuring spoon. Replace cap and follow directions below.
  • INDICATIONS & USAGE

    Other information
    • each 59 mL delivered dose contains: sodium 2.2 g
    • additional liquids by mouth are recommended while taking this product
    • 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

    enemakids

  • INGREDIENTS AND APPEARANCE
    GADAVYT ENEMA 
    dibasic sodium phosphate, monobasic sodium phosphate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-105
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC3.5 g  in 59 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC9.5 g  in 59 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:53113-105-6666 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)
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