Nystatin
500000 [USP'U] · Tablet, Film Coated
- Prescription only
- Polyene Antifungal
- Active substance
- Nystatin
- Made by
- Chartwell RX, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-12-17
Polyene Antifungal
- Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
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.
Full directions ↓Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
From the official label · 2025-12-17 · DailyMed
How it works
From this product’s own US prescribing label.
Gastrointestinal absorption of nystatin is insignificant.
Most orally administered nystatin is passed unchanged in the stool.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-17
Do not take it if
Nystatin tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- General This medication is not to be used for the treatment of systemic mycoses.
- Discontinue treatment if sensitization or irritation is reported during use.
- Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential.
- There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
- Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with nystatin.
- It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Nystatin should be given to a pregnant woman only if clearly needed.
- Nursing Mothers It is not known whether nystatin is excreted in human milk.
- Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
Quoted from the official label, section “Warnings”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics ).
Quoted from the official label, section “Overdosage”.
Side effects
- 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 Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Nystatin Tablets, USP 500,000 Units are round brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in:
- Bottles of 90:
- NDC 62135-741-90
- Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
- Manufactured by:
- Vivimed Life Sciences Private Limited Alathur, Kanchipuram – 603 110, Tamilnadu, India.
- M.L.
- No.: TN00002327 Manufactured for: Chartwell RX, LLC.
- Congers, NY 10920 Revised: 08/2023 L71669
Quoted from the official label, section “How Supplied”.
What is in it
- Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei .
- Its structural formula: C 47 H 75 NO 17 M.W.
- 926.13 Nystatin tablets, USP are for oral administration and contain 500,000 units of nystatin, USP per tablet.
- Nystatin tablets, USP contain the inactive ingredients:
- corn starch, confectioner sugar, dibasic calcium phosphate, FD&C yellow #6, FD&C red #40, FD&C blue #2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc and titanium dioxide.
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Colour dyes
FD&C yellow #6; FD&C red #40; FD&C blue #2
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - Sugars
confectioner sugar
Relevant to diabetes and dental health. - Titanium dioxide
titanium dioxide
A whitening agent no longer allowed in food in the EU (E171).
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (8)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 8 of 8
- NystatinThis onePrescription onlyChartwell RX, LLCColour dyesSugarsTitanium dioxide
- NystatinPrescription onlyAvKARESugars
- NystatinPrescription onlyBryant Ranch PrepackColour dyesSugarsTitanium dioxide
- NystatinPrescription onlyHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Colour dyesSugarsTitanium dioxide
- NystatinPrescription onlyNuCare Pharmaceuticals,Inc.Colour dyesSugarsTitanium dioxide
- NystatinPrescription onlyPreferred Pharmaceuticals Inc.Colour dyesSugarsTitanium dioxide
- NystatinPrescription onlyProficient Rx LPColour dyesSugarsTitanium dioxide
- NystatinPrescription onlyTeva Pharmaceuticals USA, Inc.Sugars
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Chartwell RX, LLC |
|---|---|
| Active substance | Nystatin |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 500000 [USP'U] |
| Form | Tablet, Film Coated |
| Route | Oral |
| Packs | 90 TABLET, FILM COATED in 1 BOTTLE |
| NDC | 62135-741 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
60 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Cream18 products
100000 U/g6
- 100000 1/g
- Suspension17 products
100000 [USP'U]/mL12
100000 U/mL5
- Ointment12 products
100000 [USP'U]/g6
100000 U/g5
- 100000 1/g
- Tablet, Coated5 products
500000 [USP'U]5
Show all forms · 6 forms
- Powder5 products
100000 [USP'U]/g5
100000 [USP'U]/g · 5 companies
- Tablet, Film Coated3 products
500000 [USP'U]3
500000 [USP'U] · 3 companies
- AvKARE
- Chartwell RX, LLC · this page
- Teva Pharmaceuticals USA, Inc.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.