FDA.reportPublic FDA data

Stratuscare Glycerin Laxative Pediatric

Manufacturer
Stratus Pharmaceuticals | Tarmac Products
Effective date
2024-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:33:25

Label at a glance#

ProductStratuscare Glycerin Laxative Pediatric
Active ingredientGlycerin
Label structure11 sections

Dosage and administration

Children 2 to under 6 years of age: Carefully insert one suppository well into child's rectum It need not melt completely to produce laxative action Generally produces bowel movement in 15 minutes to 1 hour Do not exceed one suppository daily unless directed by a doctor Children under 2 years old: Consult a doctor.

Storage and handling

Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per suppository)

OTC - ACTIVE INGREDIENT SECTION

Glycerin, USP 1g

Purpose

OTC - PURPOSE SECTION

Laxative

Use

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation (irregularity)
  • generally produces bowel movement in ¼ to 1 hour.

Warnings

WARNINGS SECTION

For rectal use only.

May cause rectal discomfort or burning sensation.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has:

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks.
OTC - STOP USE SECTION

Stop use and ask a doctor:

  • if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition.

OTC - DO NOT USE SECTION

  • Do not use laxative products for longer than 1 week unless directed by a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Children 2 to under 6 years of age:
    • Carefully insert one suppository well into child's rectum
    • It need not melt completely to produce laxative action
    • Generally produces bowel movement in 15 minutes to 1 hour
    • Do not exceed one suppository daily unless directed by a doctor
  • Children under 2 years old: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium stearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 25 Suppository Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-409-25

STRATUSCARE

INFANTS
& CHILDREN

pediatrics
Glycerin
Suppositories
Laxative

Distributed by:
STRATUS
PHARMACEUTICALS INC

25 SUPPOSITORIES

DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.

Principal Display Panel - 25 Suppository Jar Label
Principal Display Panel - 25 Suppository Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252062glycerin 1 GM pediatric Rectal SuppositoryPSN4
252062glycerin 1000 MG Rectal SuppositorySCD4
252062glycerin 1 GM pediatric Rectal SuppositorySY4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-409-12Stratuscare Glycerin Laxative Pediatric12 in 1 JARSUPPOSITORY124
58980-409-25Stratuscare Glycerin Laxative Pediatric25 in 1 JARSUPPOSITORY254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-409STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC (GLYCERIN) SUPPOSITORY [STRATUS PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20241103_6ae6d3c4-bb3b-4436-b76d-8654bf871e66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-409-12EA - Each58980-40997bca87c-57f7-4dfb-8f0d-d667ef8bf62c12015-08-04
58980-409-25EA - Each58980-409785a1b6b-78ad-42ec-b6f0-b130d0fcef5612015-08-04

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
58980-40958980-409-12, 58980-409-25

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
Water059QF0KO0RIACT
SODIUM STEARATEQU7E2XA9TGIACT

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, ORALLY DISINTEGRATING / ORAL0.85 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET / ORAL9.48 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, ORALLY DISINTEGRATING / ORAL0.85 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, ORALLY DISINTEGRATING / ORAL0.85 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET / ORAL9.48 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM STEARATESODIUM STEARATEQU7E2XA9TGTABLET / ORAL9.48 mgExact identifier — unii candidate
9 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
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
ndc (package): 58980-409-12
ndc (package): 58980-409-25
ndc (product): 58980-409
ndc11 (package): 58980040912
ndc11 (package): 58980040925
spl id: 4c627848-1463-4afc-bfd6-e310b1ef0ffa
spl set id: 6ae6d3c4-bb3b-4436-b76d-8654bf871e66

Reported adverse events (FAERS/openFDA)#

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