The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories Inc for the product Gadavyt Enema (NDC 53113-104). 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.
Dibasic sodium phosphate 7 g............. Saline Laxative
Monobasic sodium phosphate 19 g......... Saline Laxative
For rectal use only
Dosage warning: Using more than one enema in 24 hours can be harmful.
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 productThese could be signs of a serious condition.
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 |
benzalkonium chloride, disodium EDTA, purified water
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Enemaadults (Enemaadults)
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