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Vapor Inhaler
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- Active ingredient
- Levmetamfetamine 50 mg
- Other brand names
- Dosage form
- Inhalant
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2014
- Label revision date
- December 20, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Levmetamfetamine 50 mg
- Other brand names
- Dosage form
- Inhalant
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2014
- Label revision date
- December 20, 2024
- Manufacturer
- C. D. M. A. , Inc.
- Registration number
- M012
- NDC root
- 63868-267
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Levmetamfetamine is a vapor inhaler that acts as a nasal decongestant, providing temporary relief from nasal congestion caused by conditions such as colds, hay fever, and upper respiratory allergies. It works by helping to clear your nasal passages, making it easier for you to breathe when you're feeling congested.
This medication is specifically indicated for short-term use to alleviate the discomfort associated with nasal congestion, allowing you to feel more comfortable during times of illness or allergy flare-ups.
Uses
If you're dealing with nasal congestion from the common cold, hay fever, or upper respiratory allergies, this medication can provide you with temporary relief. It works by helping to clear your nasal passages, making it easier for you to breathe.
You can use this medication when you're feeling stuffy due to these conditions, allowing you to go about your day with less discomfort. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.
Dosage and Administration
When using this product, you will receive a dose of levmetamfetamine, which is a medication that helps relieve nasal congestion. Each time you use it, you will inhale 2 puffs (inhalations) in each nostril if you are an adult or a child aged 12 years and older. For children aged 6 to under 12 years, they should only take 1 puff in each nostril, and this should be done under adult supervision.
It's important to remember that you should not use this medication more often than every 2 hours. If you have a child under 6 years old, you should consult a doctor before using this product. Additionally, it is not safe for children under 2 years of age, so please avoid using it for that age group. Always follow these guidelines to ensure safe and effective use.
What to Avoid
It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than 7 days, and always follow the directions provided. Using it frequently or for an extended period can lead to a return or worsening of nasal congestion. Additionally, make sure not to exceed the recommended dosage, as doing so can pose risks to your health.
Side Effects
You may experience some temporary side effects, such as burning, stinging, sneezing, or increased nasal discharge. It's important not to exceed the recommended dosage, as using this product for more than 7 days can lead to worsening nasal congestion. If your symptoms persist, please stop using the product and consult a doctor.
If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this product. Additionally, keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.
Warnings and Precautions
It's important to follow the recommended dosage when using this medication, as exceeding it can lead to unwanted side effects. You may experience temporary burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this container with others can spread infections, so it's best to keep it for your personal use only.
For your safety, do not use this medication for more than 7 days, and always follow the directions provided. Frequent or prolonged use may actually worsen nasal congestion instead of relieving it. If your symptoms persist, stop using the medication and consult your doctor for further advice.
Keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.
Overdose
If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.
Don't wait for symptoms to worsen; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
When using this medication for children, it's important to follow specific guidelines based on their age. For adults and children aged 12 and older, the recommended dose is 2 inhalations in each nostril. If your child is between 6 and 12 years old, they should receive 1 inhalation in each nostril, but this should be done under adult supervision.
For children younger than 6 years, you should consult a doctor before use. Additionally, this medication is not recommended for children under 2 years of age, so please avoid using it for that age group. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.
Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.
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 drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, as of now, there are no known issues when combining this medication with others or with lab tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.
Always remember that discussing your full list of medications and any upcoming lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.
Storage and Handling
To ensure the best performance of your inhaler, store it in a cool, dry place at temperatures between 59°-86° F (15°-30° C). It's important to keep the inhaler tightly closed when not in use to protect it from moisture and contamination.
Once you start using the inhaler, it remains effective for at least 3 months. Always handle it with care to maintain its integrity and effectiveness.
Additional Information
No further information is available.
FAQ
What is Levmetamfetamine?
Levmetamfetamine is a vapor inhaler used as a nasal decongestant for temporary relief of nasal congestion due to colds, hay fever, and upper respiratory allergies.
How should I use Levmetamfetamine?
For adults and children 12 years and older, use 2 inhalations in each nostril. For children aged 6 to under 12 years, use 1 inhalation in each nostril with adult supervision.
Are there any side effects of using Levmetamfetamine?
Temporary burning, stinging, sneezing, or increased nasal discharge may occur. If symptoms persist, stop use and consult a doctor.
Can I use Levmetamfetamine if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using Levmetamfetamine.
How long can I use Levmetamfetamine?
Do not use Levmetamfetamine for more than 7 days. Frequent or prolonged use may cause nasal congestion to recur or worsen.
What should I do if I accidentally swallow Levmetamfetamine?
Keep Levmetamfetamine out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
What is the recommended storage for Levmetamfetamine?
Store Levmetamfetamine at 59°-86° F (15°-30° C) and keep the inhaler tightly closed.
Packaging Info
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine nasal decongestant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Inhalant | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Vapor Inhaler, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
NDC 63868-267-01, QC® QUALITY CHOICE Vapor Inhaler contains levmetamfetamine as its active ingredient. This product is formulated as a nasal decongestant, providing temporary relief of nasal congestion associated with colds, hay fever, and upper respiratory allergies. The net weight of the inhaler is 0.007 ounces (198 mg).
Uses and Indications
This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or upper respiratory allergies.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
The product delivers 0.04 to 0.150 mg of levmetamfetamine in each 800 ml of air. For adults and children aged 12 years and older, the recommended dosage is 2 inhalations in each nostril. For children aged 6 to under 12 years, with adult supervision, the dosage is 1 inhalation in each nostril.
Administration should not occur more frequently than every 2 hours. It is advised that healthcare professionals consult a physician regarding the use of this product in children under 6 years of age. The product is contraindicated for use in children under 2 years of age.
Contraindications
Use of this product is contraindicated in the following situations:
Prolonged use beyond 7 days is not recommended, as it may lead to nasal congestion recurrence or worsening.
The product should only be used as directed; exceeding the recommended dosage is contraindicated. Frequent or prolonged use may exacerbate symptoms.
Warnings and Precautions
Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product to ensure safe and effective treatment.
Warnings It is imperative that the recommended dosage is not exceeded, as doing so may lead to adverse effects. Users may experience temporary burning, stinging, sneezing, or increased nasal discharge upon application. Additionally, sharing this container among multiple users poses a risk of spreading infection.
General Precautions This product should not be used for more than 7 consecutive days. It is essential to adhere strictly to the directions provided. Frequent or prolonged use may result in a recurrence or worsening of nasal congestion.
Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare provider if symptoms persist despite treatment.
Get Emergency Medical Help Instructions This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.
Side Effects
Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge following the use of this product. It is important to adhere to the recommended dosage, as exceeding this may lead to adverse effects. The product is not intended for use beyond 7 days; frequent or prolonged use may result in the recurrence or worsening of nasal congestion.
In the event that symptoms persist, patients are advised to stop use and consult a healthcare professional. Special considerations should be taken for pregnant or breastfeeding individuals, who should seek guidance from a health professional prior to use.
Additionally, this product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended. The use of this container by more than one person may pose a risk of spreading infection.
Drug Interactions
There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.
Packaging & NDC
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine nasal decongestant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Inhalant | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients aged 12 years and older may receive 2 inhalations in each nostril. For children aged 6 to under 12 years, the recommended dosage is 1 inhalation in each nostril, administered under adult supervision.
It is advised that children under 6 years of age consult a doctor before use. The product is contraindicated in children under 2 years of age.
Geriatric Use
There is no specific information available 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, given the lack of targeted data for this population.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.
Overdosage
In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.
Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.
Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.
Nonclinical Toxicology
No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the potential toxicological profile in nonclinical settings.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children and to seek medical help or contact a Poison Control Center immediately if the medication is swallowed. It is important to inform patients that the medication should not be used for more than 7 days and must be used only as directed to avoid potential complications.
Patients should be made aware that frequent or prolonged use of the medication may lead to a recurrence or worsening of nasal congestion. They should be instructed to stop using the medication and consult a doctor if their symptoms persist. Additionally, healthcare providers should emphasize the importance of not exceeding the recommended dosage to prevent adverse effects.
Patients may experience temporary side effects, including burning, stinging, sneezing, or increased nasal discharge. It is crucial to communicate that the use of this container by more than one person may increase the risk of spreading infection.
Storage and Handling
The inhaler is supplied in a configuration that ensures its effectiveness for a minimum of three months following the first use. It is essential to keep the inhaler tightly closed when not in use to maintain its integrity and efficacy.
For optimal storage, the inhaler should be kept at a temperature range of 59° to 86° F (15° to 30° C). Proper adherence to these storage conditions is crucial for preserving the product's performance and safety.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Vapor Inhaler, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.