Active Ingredient
Active Ingredient Purpose
(in each suppository)
Glycerin, USP 2 grams ............................................Laxative
Avedana Glycerin
FDA Label NDC 43749-440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Glycerin (NDC 43749-440). 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 active ingredient, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
-relieves occasional constipation (irregularity)
-generally produces bowel movement in 1/4 to 1 hour
Warnings
For rectal use only
Do Not Use
Do not use laxative products for longer than 1 week unless directed by a doctor
Ask A Doctor Before Use If You Have
Ask a doctor before use if you have
- abdominal pain - nausea - vomiting - noticed a sudden change in bowel habits that lasts over 2 weeks
When Using This Product
When using this product you may have rectal discomfort or a burning sensation
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
-you have rectal bleeding
-you fail to have a bowel movement after use of a laxative
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
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.
Directions
adults and children 6 years and over 1 suppository per day or as directed by a doctor
children 2 to under 6 years use Child Suppositories
children under 2 years ask a doctor
-insert 1 suppository well up into the rectum and retain for 15 minutes
-it need not melt to produce laxative action
Other Information
-keep tightly closed - avoid excessive heat
Inactive Ingredients
purified water, sodium hydroxide, stearic acid
Product Label
Product Label (Label)
* Please review the disclaimer below.
