Infant Glycerin Laxative
FDA Label NDC 49348-158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Infant Glycerin Laxative (NDC 49348-158). 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, otc - ask doctor/pharmacist, otc - when using, 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


Otc - Ask Doctor/Pharmacist


Otc - When Using


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.

Otc - Pregnancy Or Breast Feeding


Keep Out Of Reach Of Children

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

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


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

Otc - Questions


Package Label

Sunmark®

COMPARE TO FLEET® ACTIVE INGREDIENT*
NDC 49348-158-05

Laxative
Suppositories

Glycerin


For fast, gentle relief of occasional constipation

PEDIATRIC

25 SUPPOSITORIES

Another Quality Product
Distributed by McKesson
One Post Street, San
Francisco, CA 94104
Money Back Guarantee
Please visit us at
www.sunmarkbrand.com

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


USE ONLY IF PRINTED
INNER SEAL IS NOT BROKEN
OR MISSING

Label (33 11025 Sm L A)

Label (33 11025 Sm L A)

* Please review the disclaimer below.