FDA.reportPublic FDA data

Microlax Enema

Manufacturer
MEDIA NETWORKS SYDNEY PTY LIMITED
Effective date
2024-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:14

Label at a glance#

ProductMicrolax Enema
Active ingredientSORBITOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Dosage Form Enema Route of Administration Rectal Visual Identification A colourless, opalescent and viscous preparation.

WARNINGS SECTION

No Warnings included on Record

INACTIVE INGREDIENT SECTION

glycerol purified water sorbic acid

INDICATIONS & USAGE SECTION

Permitted Indications No Permitted Indications included on Record Indication Requirements No Indication Requirements included on Record

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Single Medicine Product Specific Indications Rectal constipation, faecal incontinence; preparation for X-ray examination and rectoscopy

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

sodium citrate dihydrate 90 mg/mL

sodium lauryl sulfoacetate 9 mg/mL

sorbitol 625 mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONTENT OF LABELINGCONTENT OF LABELINGMicrolax Enema 5mlx12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84177-0020-1Microlax Enema1 g in 1 BOXENEMA11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84177-0020MICROLAX ENEMA ENEMA [MEDIA NETWORKS SYDNEY PTY LIMITED]11 package rows20240325_1469c434-ef23-acbe-e063-6394a90a546b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84177-002084177-0020-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
GLYCEROL FORMAL3L7GR2604EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RACTIB
SORBIC ACIDX045WJ989BIACT

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
1469c434-ef24-acbe-e063-6394a90a546b1469c434-ef23-acbe-e063-6394a90a546b2024-03-24WarningsExact identifier
spl id: 1469c434-ef24-acbe-e063-6394a90a546b
spl set id: 1469c434-ef23-acbe-e063-6394a90a546b

Reported adverse events (FAERS/openFDA)#

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