Pediatric Glycerin Laxative

Manufacturer
Cardinal Health, Inc. | Acino Products LLC
Effective date
2014-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:49

Label at a glance#

ProductPediatric Glycerin Laxative
Active ingredientGLYCERIN
Label structure12 sections

Dosage and administration

Children 2 to under 6 years: detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows: hold suppository with pointed end up carefully separate tabs with fingernail slowly pull apart by pulling tabs down on both sides remove suppository from wrapper Carefully insert one suppository well into the rectum and retain for 15 minutes It need not melt completely to produce laxative a...

Label contents#

Full prescribing information#

Drug Facts Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(per suppository)

Glycerin, USP 1 g

Purpose

OTC - PURPOSE SECTION

Laxative

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Use

INDICATIONS & USAGE SECTION

For relief of occasional constipation

Warnings

WARNINGS SECTION

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

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • abdominal pain,nausea,or vomiting.
  • a sudden change in bowel habits lasting more than 2 weeks.
  • if you have already used a laxative for a week

Stop use and ask a doctor if your child has

OTC - STOP USE SECTION

rectal bleeding or fails to have a bowel movement within one  hour of using this product.
This may indicate a serious condition.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Children 2 to under 6 years:
  • detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:
  • hold suppository with pointed end up
  • carefully separate tabs with fingernail
  • slowly pull apart by pulling tabs down on both sides
  • remove suppository from wrapper
  • Carefully insert one suppository well into the rectum and retain for 15 minutes
  • 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: consult a doctor
Acino Leader image1
Acino Leader image1

Inactive ingredients

INACTIVE INGREDIENT SECTION

sodium stearate, purified water

Other information

OTHER SAFETY INFORMATION

  • Store container tightly closed
  • Keep from excessive heat

Pediatric Glycerin Suppository Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49781-080-25

LEADER®


Compare to Fleet® active ingredient*

Pediatric Glycerin Suppositories

Laxative

SATISFACTION GUARANTEED

25 Pediatric Size

TAMPER-EVIDENT: FOR YOUR SAFETY , SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER. DO NOT USE IF WRAPPER IS TORN OR OPEN

E-Z Open Wrapper

Distributed by Cardinal Health, Inc.
Dublin, Ohio 43017
CIN 4873303
www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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

Acino GlySupp 080Acino GlySupp 080

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49781-080-252025-05-15C16284748780-19d75b9d0-7b55-f424-e053-dadaa90a57ceb14eea58-a7c1-4803-95e5-e6a13be5f12c
49781-080-252020-01-31C16284748780-19d75b9d0-7b55-f424-e053-dadaa90a57ceb14eea58-a7c1-4803-95e5-e6a13be5f12c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49781-080-25EA - Each49781-080e583b28c-da0c-428e-86e8-c2733ec72fbb12017-12-14

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
49781-08049781-080-25

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
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
514f9fc0-c9c1-4989-b5c3-8ddcf4414b78b14eea58-a7c1-4803-95e5-e6a13be5f12c2025-05-12WarningsExact identifier
spl set id: b14eea58-a7c1-4803-95e5-e6a13be5f12c

Reported adverse events (FAERS/openFDA)#

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