Active Ingredient (In Each Suppository)
Glycerin 1g
Glycerin Suppository
FDA Label NDC 37808-399
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Glycerin (NDC 37808-399). 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, directions - single daily dose, other information, 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 occassional constipation
- this product generally produces bowel movement in 1/4 to 1 hour
Warnings
For rectal use only
May cause rectal discomfort or a 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 formore than 1 week
Stop Use And Consult A Doctor If Child Has
- rectal bleeding
- no bowel movement within 1 hour using this product
These symptoms may indicate a serious condition.
Directions - Single Daily Dose
children 2 to under 6 years - 1 suppository, or as directed by a doctor
chidren under 2 - 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
Questions Or Comments?
1-800-492-5988
Label
The product package shown below represents a sample of that currently in use. Additional packaging may also be available.
Pediatric Glycerin Suppositories, 25 count
Distributed by H-E-B, San Antonio, TX 78204 1002
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