GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC]

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GADAVYT ENEMA (DIBASIC SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE) LIQUID [GADAL LABORATORIES INC]
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NDC 53113-105-66
Set ID 924882a6-a8e6-4869-b6a6-a2fd931fe248
Category HUMAN OTC DRUG LABEL
Packager Gadal Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART334
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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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