Label: MICROLAX ENEMA enema

  • NDC Code(s): 84177-0020-1
  • Packager: MEDIA NETWORKS SYDNEY PTY LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 24, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    CONTENT OF LABELINGMicrolax Enema 5mlx12

  • INGREDIENTS AND APPEARANCE
    MICROLAX ENEMA 
    microlax enema enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84177-0020
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL625 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84177-0020-11 g in 1 BOX; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2024
    Labeler - MEDIA NETWORKS SYDNEY PTY LIMITED (748621327)
    Registrant - MEDIA NETWORKS SYDNEY PTY LIMITED (748621327)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDIA NETWORKS SYDNEY PTY LIMITED748621327manufacture(84177-0020)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!