Active Ingredient (In Each Suppository)
Glycerin 1.2 g
Glycerin
FDA Label NDC 17856-0222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Glycerin (NDC 17856-0222). 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 (in each suppository), purpose, uses, warnings, ask a doctor before using any laxative if child has, stop use and consult a doctor if child has, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Uses
- for relief of occasional constipation
- this product generally produces a bowel movement in 1/4 to 1 hour
Warnings
For rectal use only
May cause rectal discomfort of burning sensation
Ask A Doctor Before Using Any Laxative If Child Has
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Stop Use And Consult A Doctor If Child Has
- rectal bleeding
- no bowel movement after using this product
These symptoms may indicate a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Single daily dosage
Children 2 to under 6 years 1 suppository, or as directed by a doctor
children under 2 years ask a doctor
Insert suppository well up into rectum.
Suppository need not melt completely to produce laxative action.
Other Information
- Store container tightly closed.
- Keep away from excessive heat.
Inactive Ingredients
purified water, sodium hydroxide, stearic acid
Pediatriic Glycerin Suppositories
The product shown represents a sample of that currently in use. Additional packaging may also be available.
Pediatric Glycerin Suppositories 30 & 60 per cases.
Distributed by:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
* Please review the disclaimer below.
