Microlax Enema by MEDIA NETWORKS SYDNEY PTY LIMITED MICROLAX ENEMA enema

Microlax Enema by

Drug Labeling and Warnings

Microlax Enema by is a Otc medication manufactured, distributed, or labeled by MEDIA NETWORKS SYDNEY PTY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

WARNINGS

No Warnings included on Record

INACTIVE INGREDIENT

glycerol purified water sorbic acid

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

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

ACTIVE INGREDIENT

Active Ingredients

sodium citrate dihydrate 90 mg/mL

sodium lauryl sulfoacetate 9 mg/mL

sorbitol 625 mg/mL

PRINCIPAL DISPLAY PANEL

Microlax Enema 5mlx12

INGREDIENTS AND APPEARANCE

MICROLAX ENEMA 
microlax enema enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84177-0020
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)	SORBITOL	625 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	90 mg  in 1 g
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)	9 mg  in 1 g
GLYCEROL FORMAL (UNII: 3L7GR2604E)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84177-0020-1	1 g in 1 BOX; Type 0: Not a Combination Product	03/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2024

Labeler - MEDIA NETWORKS SYDNEY PTY LIMITED (748621327)

Registrant - MEDIA NETWORKS SYDNEY PTY LIMITED (748621327)

Establishment
Name	Address	ID/FEI	Business Operations
MEDIA NETWORKS SYDNEY PTY LIMITED		748621327	manufacture(84177-0020)