Product Details

NYSTATIN 100 MU-ML SUS 473 ML

Manufacturer: PHARMACEUTICAL ASSOC

MFG#: 00121-0868-16

NDC: 00121-0868-16

PID: 226579

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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AA
DESI2 Drug Ind AA
Drug Category -
Drug Category -
Drug Type Code N
Drug Type Code N
FDA Approval Date 08/01/2016
FDA Approval Date 08/01/2016
FDA Therap Equiv ML
FDA Therap Equiv ML
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date 1
Unit 473
Unit 473
Units Per Pkg 01/07/2016
Units Per Pkg 01/07/2016
Active Ingredients 2889 nystatin 1400619
Active Ingredients 2889 nystatin 1400619
AHFS Class 8142800 POLYENE ANTIFUNGALS
AHFS Class 8142800 POLYENE ANTIFUNGALS
DEA Class NC
DEA Class NC
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 9537 nystatin ORAL ORAL SUSP 100000/ML
Gen Code and Des 9537 nystatin ORAL ORAL SUSP 100000/ML
Inactive Ingredients 10141 red dye; 10143 yellow dye; 1539 ethyl alcohol 64175; 2468 propylene glycol 57556; 2598 sucrose 57501; 3203 paraben 99967; 6364 magnesium aluminum silicate 1327431; 7989 peppermint
Inactive Ingredients 10141 red dye; 10143 yellow dye; 1539 ethyl alcohol 64175; 2468 propylene glycol 57556; 2598 sucrose 57501; 3203 paraben 99967; 6364 magnesium aluminum silicate 1327431; 7989 peppermint
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 100MU-ML
Strength 100MU-ML
Common Brand Name COMMON BRAND NAME(S): Mycostatin
Common Brand Name COMMON BRAND NAME(S): Mycostatin
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 473
Drug Form Pack Size 473
Form SUSPENSION
Form SUSPENSION
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 473
Unit Size 473
How to Use HOW TO USE: Use this medication as directed by your doctor, usually 4 times a day. Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Unless your doctor instructs you otherwise, use as follows: Place half of the dose in one side of the mouth. Swish it around the mouth, gargle, and swallow or spit out as directed. Keep the liquid in your mouth for as long as possible. Then repeat with the remaining half of the dose in the other side of the mouth. Avoid eating for 5 to 10 minutes after using this medication. It may take from several days to several months to complete treatment. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. The dosage is based on your medical condition and response to treatment. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow the infection to continue, resulting in a return of the infection. Tell your doctor if your condition lasts after several days of treatment or if it gets worse.
How to Use HOW TO USE: Use this medication as directed by your doctor, usually 4 times a day. Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Unless your doctor instructs you otherwise, use as follows: Place half of the dose in one side of the mouth. Swish it around the mouth, gargle, and swallow or spit out as directed. Keep the liquid in your mouth for as long as possible. Then repeat with the remaining half of the dose in the other side of the mouth. Avoid eating for 5 to 10 minutes after using this medication. It may take from several days to several months to complete treatment. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. The dosage is based on your medical condition and response to treatment. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow the infection to continue, resulting in a return of the infection. Tell your doctor if your condition lasts after several days of treatment or if it gets worse.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (NYE-stat-in)
Phonetic Pronunciation (NYE-stat-in)
Precautions PRECAUTIONS: Before taking nystatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV disease, diabetes, kidney disease. This product contains sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about the safe use of this product. Denture wearers need to be careful to properly clean and maintain their dentures during treatment with this medication. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking nystatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV disease, diabetes, kidney disease. This product contains sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about the safe use of this product. Denture wearers need to be careful to properly clean and maintain their dentures during treatment with this medication. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Mouth irritation, diarrhea, nausea, vomiting, or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fast heartbeat, wheezing, muscle pain. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Mouth irritation, diarrhea, nausea, vomiting, or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fast heartbeat, wheezing, muscle pain. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from heat and light. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from heat and light. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat fungal infections of the mouth. Nystatin is an antifungal that works by stopping the growth of fungus. Nystatin suspension should not be used to treat fungal infections of the blood.
Uses USES: This medication is used to treat fungal infections of the mouth. Nystatin is an antifungal that works by stopping the growth of fungus. Nystatin suspension should not be used to treat fungal infections of the blood.

Frequently Asked Questions (FAQs)

The cost of NYSTATIN 100 MU-ML SUS 473 ML is $available for registerd members only

NYSTATIN 100 MU-ML SUS 473 ML is manufactured by PHARMACEUTICAL ASSOC.

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