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Medicine in DR Congo · official US FDA label

Nystatine 100 000 UI

Nystatine (nystatin) · comprimé vaginal

Essential medicine in DR Congo (LNME)Authorized in DR Congo

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This is a US label.

The official US FDA label for nystatin, effective August 19, 2026, describes products sold in the United States. The medicine sold in DR Congo may differ in strength, form or approved uses: ask a pharmacist or a doctor.

Official US FDA label for nystatin

Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. The full label on DailyMed.

Uses

INDICATIONS AND USAGE Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Dosage

US dosage, for products sold in the United States. For a medicine bought in DR Congo, follow its box, its leaflet or your pharmacist.

DOSAGE AND ADMINISTRATION The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

Side effects

ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General . ) Gastrointestinal Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Where to find it in DR Congo

Not in stock in our pharmacies right now

Stock changes with every sale. Search by substance: a medicine with the same composition may be available.

Composition

SubstanceStrengthATC code
Nystatine (nystatin)100 000 UI—

Marketing authorization in DR Congo

From the register of the ACOREP (the Congolese pharmaceutical regulatory authority).

  • Authorization number

    MS.1253/10/05/DGM/0924/2021

    Valid from July 5, 2021 until July 5, 2026

    Holder
    MEDICO PLUS Av. Marché n° 1106, commune de Gombe, ville de Kinshasa, R.D Congo
    Manufacturer
    Axelia Laboratories Plot. N° 26, PIDCO,Village Mahim, Palghar, Maharashtra 401 404/India
    Country
    Inde
  • Authorization number

    MS.1253/10/05/DGM/0205/2021

    Valid from February 8, 2021 until February 8, 2026

    Holder
    PHARMEX Av. Bakongo n° 10, commune de Barumbu, ville de Kinshasa, R.D Congo
    Manufacturer
    Pharmax India Private Lmt. Plot N°9, Kurla Industrial Estate, Narayan Nagar, Ghatkopar West, Mumbai, Maharashtra 400086/India
    Country
    Inde

Sources

  • ●Labels: U.S. Food and Drug Administration, openFDA (public domain). Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. DailyMed.
  • ●English names of substances: RxNorm, U.S. National Library of Medicine.
  • ●Marketing authorizations: register of the ACOREP, DR Congo, version of February 4, 2026.
  • ●Essential medicines: national list of essential medicines of DR Congo (LNME).

Public information, for reference only: it does not replace the advice of a pharmacist or a doctor. Vimpia writes nothing about how to use a medicine and translates nothing: the label is the US FDA's, unchanged; names, composition and authorizations come from the official sources above.