FDA.reportPublic FDA data

Infant Glycerin Laxative

Manufacturer
Physicians Total Care, Inc.
Effective date
2010-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:17

Label at a glance#

ProductInfant Glycerin Laxative
Active ingredientGLYCERIN
Label structure9 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Glycerin, USP 80.7%

PURPOSE

OTC - PURPOSE SECTION

Laxative

USE

INDICATIONS & USAGE SECTION

For relief of occasional constipation

WARNINGS

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Enter section text here

OTC - WHEN USING SECTION

Enter section text here

OTC - PREGNANCY OR BREAST FEEDING SECTION

Enter section text here

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

sodium stearate, purified water

QUESTIONS

OTC - QUESTIONS SECTION

Adverse Drug Event Call: (800) 616-2471

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-6186-0


Infant
GLYCERIN
SUPPOSITORIES


Rectal evacuant
For relief of
temporary constipation

12 Infant Suppositories

image of package label for 12image of package label for 12

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052358glycerin 1.3 GM Pediatric Rectal SuppositoryPSN1
1052358glycerin 1300 MG Rectal SuppositorySCD1
1052358glycerin 1.3 GM Rectal SuppositorySY1
1052358glycerin 80.7 % Pediatric Rectal SuppositorySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-6186-02019-09-24C16284748780-19350213a-4250-c013-e053-90daa90a1393d7a8c09d-d829-4dea-8bc4-4299ecc99dda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-6186-0Infant Glycerin Laxative12 in 1 JARSUPPOSITORY121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-6186INFANT GLYCERIN LAXATIVE (GLYCERIN) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]11 package rows20101104_d7a8c09d-d829-4dea-8bc4-4299ecc99dda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERINACTIVE MOIETYPDC6A3C0OX1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TG1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-618654868-6186-0
0904-2666

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
SODIUM STEARATEQU7E2XA9TGIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET / ORAL9.48 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, ORALLY DISINTEGRATING / ORAL0.85 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7a41cfe2-4505-4db2-91e7-51493a47f497d7a8c09d-d829-4dea-8bc4-4299ecc99dda2010-10-28WarningsExact identifier
spl id: 7a41cfe2-4505-4db2-91e7-51493a47f497
spl set id: d7a8c09d-d829-4dea-8bc4-4299ecc99dda

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.