FDA.reportPublic FDA data

Avedana Glycerin

Manufacturer
Unipack LLC
Effective date
2024-01-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:06:38

Label at a glance#

ProductAvedana Glycerin Laxative
Active ingredientGLYCERIN
Label structure13 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 1/4 to 1 hour

Dosage and administration

adults and children 6 years and over                     1 suppository per day or as directed by a doctor children 2 to under 6 years                                   use Child Suppositories children under 2 years                                          ask a doctor insert 1 suppository well up into the rectum and retain for 15 minutes it need not melt to produce laxative action

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                                      Purpose
(in each suppository)
Glycerin, USP 2 grams ............................................Laxative

Uses

OTC - PURPOSE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/4 to 1 hour

Warnings

WARNINGS SECTION

For rectal use only

Do not use

INDICATIONS & USAGE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

When using this product

OTHER SAFETY INFORMATION

When using this product you may have rectal discomfort or a burning sensation

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of a laxative

These could be signs of a serious condition.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over                     1 suppository per day or as directed by a doctor
children 2 to under 6 years                                   use Child Suppositories
children under 2 years                                          ask a doctor

  • insert 1 suppository well up into the rectum and retain for 15 minutes
  • it need not melt to produce laxative action

Other information

OTHER SAFETY INFORMATION

-keep tightly closed - avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hydroxide, stearic acid

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avedana ® Glycerin Suppositories | 100 count in a Jar |

Product Label 100 ct Glycerin SuppositoriesProduct Label 100 ct Glycerin Suppositories

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
104155glycerin 2 GM Rectal SuppositoryPSN8
104155glycerin 2000 MG Rectal SuppositorySCD8
104155glycerin 2 GM Rectal SuppositorySY8

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
43749-440-002020-10-26C16284748780-19d75b9d0-9b20-f424-e053-dadaa90a57ceAvedana ® Glycerin Suppositories 100 count Drug Facts
43749-440-002020-01-31C16284748780-19d75b9d0-9b20-f424-e053-dadaa90a57ceAvedana ® Glycerin Suppositories 100 count Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-440-00Avedana GlycerinLaxative100 in 1 JARSUPPOSITORY1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-440AVEDANA GLYCERIN LAXATIVE (GLYCERIN) SUPPOSITORY [UNIPACK LLC]8Legacy NDC, 1 package rows20240105_4c1f7ab1-6274-4dd1-bbfc-869dec5797cf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-440-00EA - Each43749-440045153b5-d2f2-43eb-b0b1-e845b64a960012024-04-05
43749-440-25EA - Each43749-440da3fc0a5-d5c1-4024-bc84-6b9d7d03891c12024-04-05

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-44043749-440-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

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
0e239b53-79e2-8bd2-e063-6294a90ab85e4c1f7ab1-6274-4dd1-bbfc-869dec5797cf2024-01-04WarningsExact identifier
spl id: 0e239b53-79e2-8bd2-e063-6294a90ab85e
spl set id: 4c1f7ab1-6274-4dd1-bbfc-869dec5797cf

Reported adverse events (FAERS/openFDA)#

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