Glycerin
FDA Label NDC 54868-2923

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Glycerin (NDC 54868-2923). 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), use, warnings, ask a doctor before using any laxative if you have, stop use and consult a doctor if you have, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Suppository)

Glycerin 2 g.................Hyperosmotic Laxative

Use

For relief of occasional constipation.

Warnings

For rectal use only.

May cause rectal discomfort or a burning sensation.

Ask A Doctor Before Using Any Laxative If You Have

  • 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 You Have

  • rectal bleeding
  • no bowel movement after using 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

adults and children 6 years and over
1 suppository, or as directed by a doctor
children 2 to under 6 years
use Pedia-Lax Glycerin Suppositories
children under 2 years
ask a doctor

Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.

Other Information

  • This product generally produces a bowel movement in 1/4 to 1 hour.
  • Store container tightly closed.
  • Keep away from excessive heat.
  • MOUTH OF JAR SEALED FOR SAFETY. IF FOIL IMPRINTED WITH GREEN FLEET EMBLEM IS BROKEN OR MISSING, DO NOT USE.

Inactive Ingredients

edetate disodium, purified water, sodium hydroxide, stearic acid

Questions?

1-866-255-6960 or www.fleetlabs.com

Principal Display Panel

Glycerin Suppositories laxative 

12 Adult Suppositories

NDC 54868-2923-0

Image Of Label (2923)

Image Of Label (2923)




Additional barcode label appied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma     74146

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