Gadavyt Enema
FDA Label NDC 53113-105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories Inc for the product Gadavyt Enema (NDC 53113-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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

Otc - Purpose

Usesfor 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

Otc - 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,

ask a health professional before use.

Otc - 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

Otc - Questions

Questions or comments?

305-382-3288

* Please review the disclaimer below.