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Gadavyt Enema by Gadal Laboratories Inc

Medically reviewed on October 31, 2017

Dosage form: liquid
Ingredients: SODIUM PHOSPHATE, DIBASIC 3.5g in 59mL, SODIUM PHOSPHATE, MONOBASIC 9.5g in 59mL
Labeler: Gadal Laboratories Inc
NDC Code: 53113-105

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 Facts

Active ingredients (in each 59 mL delivered dose)

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

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

Uses

for relief of occasional constipation

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

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

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. (1-800-222-1222)

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.

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 ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

305-382-3288

GADAVYT ENEMA 
dibasic sodium phosphate, monobasic sodium phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-105
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC9.5 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
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)

 
Gadal Laboratories Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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