Infant Glycerin Laxative
FDA Label NDC 54868-6186

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 Infant Glycerin Laxative (NDC 54868-6186). 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, purpose, use, warnings, do not use, ask a doctor, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Glycerin, USP 80.7%

Purpose

Laxative

Use

For relief of occasional constipation

Warnings

For rectal use only. May cause rectal discomfort or a burning sensation.

Do Not Use

  • more than one per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if seal under product lid is damaged, missing or broken.

Ask A Doctor

  • before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
  • if you are pregnant or nursing a baby

Stop Use And Ask A Doctor

  • if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep Out Of Reach Of Children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Ask Doctor/Pharmacist

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Otc - When Using

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Otc - Pregnancy Or Breast Feeding

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Directions

  • Children 2 - 6 years of age: carefully insert one suppository well into the rectum
  • Do not use more than once per day
  • Generally produces a bowel movement in 15 minutes to 1 hour
  • Children under 2 years of age: ask a doctor.

Other Information

  • Store container tightly closed
  • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).

Inactive Ingredients

sodium stearate, purified water

Questions

Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

NDC 54868-6186-0


Infant
GLYCERIN
SUPPOSITORIES


Rectal evacuant
For relief of
temporary constipation

12 Infant Suppositories

Compare to Fleet® Glycerin Suppositories*


*This product is not manufactured or distributed by C.B.Fleet co., owner of
the registered trademark Fleet®.


Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA

Reorder No. 233874
M-54 Rev 6/08

DO NOT USE IF PRINTED
INNER SEAL IS BROKEN
OR MISSING



Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

* Please review the disclaimer below.