Active Ingredient (In Each Suppository)
Glycerin 1 g
Glycerin Suppository
FDA Label NDC 68016-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium Llc for the product Glycerin (NDC 68016-161). 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 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
Hyperosmotic 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 Laxative If Child Has
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than two weeks
- already used a laxative for more than 1 week
Stop Use And Consult A Doctor If Child Has
- rectal bleeding
- no bowel movement within 1 hour of 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
| 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 intorectum.
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
Pediatric Glycerin Suppositories, 25 Count
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The product package shown above represents a sample of that currently in use. Additional packaging may also be available.
PediatricGlycerin Suppositories, 25 count
Distributed by Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087
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