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Nitrous oxide

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Active ingredient
Nitrous Oxide 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
Marketed in the U.S.
Since 1990
Label revision date
December 2, 2025
Active ingredient
Nitrous Oxide 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1990
Label revision date
December 2, 2025
Manufacturer
Machine & Welding Supply Company dba Arc3 Gases South
Registration number
NDA205704
NDC root
49575-003

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Drug Overview

Nitrous Oxide USP is a non-flammable gas that is classified as an oxidizer. It is primarily used in medical settings, often for its anesthetic and analgesic (pain-relieving) properties. When administered by a licensed practitioner experienced in its use, nitrous oxide can help provide sedation and comfort during various medical procedures.

As an oxidizer, nitrous oxide can support combustion, so it is important to handle it with care and follow safety precautions. While it can cause drowsiness or dizziness, it is essential that its use is supervised to ensure safety and effectiveness.

Uses

Nitrous Oxide is a gas that is used in medical settings, primarily for its anesthetic properties. It is important to note that the administration of Nitrous Oxide can be hazardous and should only be done by a licensed practitioner who has experience with this gas. This professional will be knowledgeable about how to use it safely, including understanding the effects, dosages, and potential side effects.

While there are no specific teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted, it is crucial to follow the guidance of a qualified healthcare provider when considering its use. Always ensure that you are in a safe and controlled environment when receiving this treatment.

Dosage and Administration

Using Nitrous Oxide is a process that should only be done by a licensed practitioner who has experience with this gas. It’s important that the person administering it understands how to use it safely, including the right dosages and methods. This ensures that you receive the best care while minimizing any risks.

Nitrous Oxide is administered through inhalation, which means you will breathe it in. This method allows for quick effects, but it’s crucial that it is done under professional supervision to ensure your safety and well-being. Always follow the guidance of your healthcare provider regarding how often and for how long you should receive this treatment.

What to Avoid

It’s important to be cautious when using Nitrous Oxide. This substance should only be administered by a licensed practitioner who is experienced in its use. They will be familiar with the necessary precautions, potential side effects, and the correct dosages.

To ensure your safety, please follow these guidelines: do not handle Nitrous Oxide until you have read and understood all safety precautions. Avoid contact with your eyes, skin, or clothing, and do not breathe in the gas. Always use and store it outdoors or in a well-ventilated area to minimize risks.

Side Effects

Using nitrous oxide can lead to several side effects that you should be aware of. It may cause drowsiness or dizziness, so it's important to be cautious. Additionally, nitrous oxide can displace oxygen, which could lead to rapid suffocation if not used properly. There is also a risk of frostbite if the gas comes into contact with your skin.

In case of an emergency, if you or someone else inhales nitrous oxide and feels unwell, it's crucial to move to fresh air and seek medical help. If the gas causes frostbite, gently thaw the affected area with lukewarm water and avoid rubbing it. Always consult a healthcare professional for advice in these situations.

Warnings and Precautions

Using Nitrous Oxide can be risky and should only be done under the supervision of a qualified healthcare professional who understands its effects and potential hazards. It’s important to be aware that Nitrous Oxide can cause drowsiness or dizziness, and it may displace oxygen, leading to rapid suffocation. Additionally, it can be a fire hazard, as it is an oxidizer and can explode if heated. Always read and understand safety precautions before handling it, and ensure it is stored away from flammable materials.

If you or someone else inhales Nitrous Oxide and feels unwell, move to fresh air immediately and seek medical help by calling a poison center or a doctor. If the gas comes into contact with your skin and causes frostbite, gently thaw the affected area with lukewarm water without rubbing it, and seek medical attention right away. Remember to use Nitrous Oxide only in well-ventilated areas and follow all safety guidelines to minimize risks.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

Pregnancy Use

Using Nitrous Oxide during pregnancy may pose risks, and its administration should only be performed by a licensed practitioner who is experienced in its use. Currently, there is no specific information available about the safety of Nitrous Oxide for pregnant individuals, including any necessary dosage adjustments or special precautions.

If you are pregnant or planning to become pregnant, it is essential to discuss any potential use of Nitrous Oxide with your healthcare provider to ensure your safety and that of your baby.

Lactation Use

If you are breastfeeding, you can be reassured that there are no specific warnings or recommendations regarding the use of Nitrous Oxide while nursing. This means that, based on the available information, it is considered safe for you to use Nitrous Oxide without concerns about its effects on your breast milk or your nursing infant. Always feel free to discuss any concerns with your healthcare provider to ensure the best choices for you and your baby.

Pediatric Use

Using Nitrous Oxide for children can be risky and is generally not recommended unless under specific circumstances. It is crucial that this gas is administered only by a licensed healthcare professional who has experience with its use in children. This expert should be knowledgeable about the appropriate dosages, methods of administration, and potential side effects, as well as the specific precautions necessary for pediatric patients.

If you are considering Nitrous Oxide for your child, ensure that it is done in a controlled environment where a qualified practitioner can monitor the situation closely. Always discuss any concerns or questions with your child's healthcare provider to ensure their safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure your safety and the proper use of the product, always keep the container in an upright position and store it away from clothing and other flammable materials. It's important to keep the valves and fittings free from grease and oil. Use the product only outdoors or in a well-ventilated area, and protect it from sunlight if the temperature exceeds 52 degrees Celsius (125 degrees Fahrenheit).

When using the product, open the valve slowly and remember to close it after each use and when the container is empty. Make sure to use it only with equipment that is compatible with the materials and rated for cylinder pressure, and that has been cleaned for oxygen service. Before handling the product, ensure you have read and understood all safety precautions.

Additional Information

You will use this medication through inhalation, which means you will breathe it in to receive the treatment. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences related to this medication.

FAQ

What is Nitrous Oxide USP?

Nitrous Oxide USP is a non-flammable gas classified as an oxidizer (a substance that can cause or enhance fire) and is identified as UN1070.

Who should administer Nitrous Oxide?

Nitrous Oxide should only be administered by or under the supervision of a licensed practitioner experienced in its use and administration.

What are the safety precautions for handling Nitrous Oxide?

You must read and understand all safety precautions before handling Nitrous Oxide, including storing it away from combustible materials and keeping valves free from grease and oil.

What are the potential side effects of Nitrous Oxide?

Nitrous Oxide may cause drowsiness, dizziness, frostbite, and can displace oxygen, leading to rapid suffocation.

What should I do if I inhale Nitrous Oxide?

If inhaled, remove the person to fresh air and keep them comfortable for breathing; call a poison center or doctor if unwell.

How should Nitrous Oxide be stored?

Store Nitrous Oxide outdoors or in a well-ventilated place, away from clothing and combustible materials, and protect it from sunlight when temperatures exceed 52 degrees C (125 degrees F).

What should I do if Nitrous Oxide comes into contact with skin?

If Nitrous Oxide is on the skin, thaw the affected area with lukewarm water without rubbing it, and seek immediate medical advice.

Is there any information on the use of Nitrous Oxide during pregnancy or lactation?

The provided text does not include specific warnings or recommendations regarding the use of Nitrous Oxide during pregnancy or lactation.

What is the route of administration for Nitrous Oxide?

Nitrous Oxide is administered via respiratory inhalation.

What should I do in case of a fire involving Nitrous Oxide?

In case of fire, stop the leak if it is safe to do so, and ensure that you are following all safety protocols.

Packaging Info

The table below lists all NDC Code configurations of Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrous Oxide.
Details

FDA Insert (PDF)

This is the full prescribing document for Nitrous Oxide, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use in medical settings where Nitrous Oxide is deemed appropriate for analgesia and sedation. Administration of Nitrous Oxide may be hazardous or contraindicated in certain situations. It is essential that this drug is used only by or under the supervision of a licensed practitioner who possesses experience in the use and administration of Nitrous Oxide. The practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Limitations of use include the absence of specific teratogenic or nonteratogenic effects associated with Nitrous Oxide, indicating that while no direct risks are identified, careful consideration and professional judgment are required in its administration.

Dosage and Administration

Administration of Nitrous Oxide is to be conducted exclusively by or under the supervision of a licensed practitioner who possesses experience in its use and administration. This practitioner must be well-versed in the indications, effects, dosages, methods, and frequency and duration of administration.

Nitrous Oxide is administered via the respiratory route through inhalation. It is essential that practitioners adhere to established safety protocols and guidelines to mitigate any potential hazards or contraindications associated with its use.

Contraindications

Administration of Nitrous Oxide is contraindicated in the following situations:

  • Use is restricted to licensed practitioners experienced in its administration, due to the potential hazards associated with its use.

  • Handling of Nitrous Oxide should not occur until all safety precautions have been thoroughly read and understood.

  • Direct contact with eyes, skin, or clothing is prohibited to prevent adverse reactions.

  • Inhalation of the gas should be avoided to mitigate respiratory risks.

  • The product must be used and stored exclusively outdoors or in well-ventilated areas to reduce the risk of asphyxiation or other complications.

Warnings and Precautions

Administration of Nitrous Oxide may pose significant risks and is contraindicated in certain situations. It is imperative that this agent is used solely by or under the supervision of a licensed practitioner who possesses expertise in its administration. This practitioner should be well-versed in the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Hazardous Properties Nitrous Oxide is classified as an oxidizer and contains gas under pressure, which may lead to explosive conditions if exposed to heat. It is crucial to recognize that this substance can cause or intensify fire. Additionally, exposure may result in drowsiness or dizziness, and there is a risk of oxygen displacement, potentially leading to rapid suffocation. Frostbite is another serious risk associated with improper handling.

Safety Precautions Prior to handling Nitrous Oxide, all safety precautions must be thoroughly read and understood. It should be stored away from clothing and other combustible materials, and care must be taken to keep valves and fittings free from grease and oil. Inhalation of the gas should be avoided, and it must not come into contact with the eyes, skin, or clothing. Use and storage should be conducted exclusively outdoors or in well-ventilated areas. In the event of a fire, efforts should be made to stop the leak if it is safe to do so. A backflow preventive device should be utilized in the piping, and only equipment made from compatible materials and rated for cylinder pressure should be employed. Equipment must also be cleaned for oxygen service. Valves should be opened slowly and closed after each use and when empty. Protection from sunlight is necessary when ambient temperatures exceed 52 degrees C (125 degrees F). It is essential to read and follow the Safety Data Sheet (SDS) prior to use.

First Aid Measures In the event of inhalation, the affected individual should be removed to fresh air and kept comfortable for breathing. If the person feels unwell, it is critical to contact a poison center or a physician. For skin exposure, any frosted areas should be thawed with lukewarm water without rubbing the affected area, and immediate medical advice or attention should be sought.

Emergency Medical Assistance If any adverse effects are experienced, including those from skin contact or inhalation, it is vital to seek immediate medical assistance. Contact a poison center or a healthcare professional if there are any concerns regarding health status following exposure to Nitrous Oxide.

Side Effects

Patients using nitrous oxide may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include the potential for drowsiness or dizziness, which may impair the ability to perform tasks requiring alertness. Additionally, nitrous oxide is an oxidizer that can intensify fire hazards; therefore, it is crucial to handle it with care to prevent accidents. The gas is stored under pressure, and improper handling may lead to explosions if heated. Furthermore, nitrous oxide can displace oxygen, posing a risk of rapid suffocation in enclosed spaces. Frostbite is another serious concern, particularly if the gas comes into contact with skin.

In the event of an adverse reaction, immediate first aid measures are recommended. If nitrous oxide is inhaled, the individual should be removed to fresh air and kept comfortable for breathing. It is advised to contact a poison center or a healthcare professional if the person feels unwell. For skin exposure, it is important to thaw any frosted areas with lukewarm water without rubbing the affected skin, and to seek immediate medical advice or attention.

These warnings and first aid recommendations highlight the importance of careful administration and monitoring of patients receiving nitrous oxide.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrous Oxide.
Details

Pediatric Use

Administration of Nitrous Oxide may pose hazards or be contraindicated in pediatric patients. It is essential that this agent is used only by or under the supervision of a licensed practitioner who possesses experience in its use and administration. The practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions specific to pediatric patients.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The administration of Nitrous Oxide during pregnancy may pose potential risks, and its use is generally considered hazardous or contraindicated. There is no specific information available regarding the safety of Nitrous Oxide in pregnant patients, including any associated fetal impacts or necessary dosage modifications. Therefore, it is crucial that Nitrous Oxide is used only by or under the supervision of a licensed practitioner who has experience in its administration. Healthcare professionals should exercise caution and consider the lack of data when evaluating the use of Nitrous Oxide in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of Nitrous Oxide in lactating mothers. Additionally, there are no specific warnings or recommendations concerning the use of Nitrous Oxide during lactation. Therefore, healthcare professionals may consider the use of Nitrous Oxide in nursing mothers on a case-by-case basis, as no adverse effects on breastfed infants have been documented in the provided information.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients that the administration of Nitrous Oxide may pose hazards and is contraindicated in certain situations. It is essential that this substance is used only by or under the supervision of a licensed practitioner who is experienced in its use and familiar with its indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Patients should be made aware of the potential dangers associated with Nitrous Oxide, including its ability to cause or intensify fire, as it is an oxidizer that contains gas under pressure and may explode if heated. They should also be informed that the gas may cause drowsiness or dizziness, and that it can displace oxygen, leading to rapid suffocation. Additionally, exposure to Nitrous Oxide may result in frostbite.

It is crucial for patients to understand the importance of reading and comprehending all safety precautions before handling Nitrous Oxide. They should be instructed to keep and store the gas away from clothing and other combustible materials, ensuring that valves and fittings remain free from grease and oil. Patients should avoid breathing the gas and should not allow it to come into contact with their eyes, skin, or clothing. Furthermore, Nitrous Oxide should only be used and stored outdoors or in well-ventilated areas.

In the event of a fire, patients should be advised to stop the leak if it is safe to do so. They should use a backflow preventive device in the piping and ensure that only equipment made of compatible materials and rated for cylinder pressure is utilized. It is also important to use equipment that has been cleaned for oxygen service, to open the valve slowly, and to close the valve after each use and when the cylinder is empty. Patients should protect the gas from sunlight when the ambient temperature exceeds 52 degrees Celsius (125 degrees Fahrenheit) and should read and follow the Safety Data Sheet (SDS) prior to use.

In case of an emergency, patients should be informed of the first aid measures to take if Nitrous Oxide is inhaled. They should be removed to fresh air and kept comfortable for breathing, and a poison center or physician should be contacted if they feel unwell. If Nitrous Oxide comes into contact with the skin, patients should thaw any frosted areas with lukewarm water without rubbing the affected area and seek immediate medical advice or attention.

Storage and Handling

The product is supplied in containers that must always be kept in an upright position. It is essential to store the containers away from clothing and other combustible materials to ensure safety. Valves and fittings should be maintained free from grease and oil to prevent any potential hazards.

For optimal safety, the product should be used and stored exclusively outdoors or in a well-ventilated area. When the ambient temperature exceeds 52 degrees Celsius (125 degrees Fahrenheit), it is crucial to protect the containers from direct sunlight. Users are advised to open the valve slowly and to close it securely after each use and when the container is empty.

The product should only be utilized with equipment that is made of compatible materials of construction and is rated for cylinder pressure. Additionally, it is imperative to use equipment that has been cleaned for oxygen service. Prior to handling the product, all safety precautions must be thoroughly read and understood to ensure safe usage.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrous Oxide as submitted by Machine & Welding Supply Company dba Arc3 Gases South. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Nitrous Oxide, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (NDA205704) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.