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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 2021
- 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 2021
- Label revision date
- December 20, 2024
- Manufacturer
- Supervalu Inc.
- Registration number
- M012
- NDC root
- 41163-031
- 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
EQUALINE® is a nasal decongestant vapor inhaler that contains levmetamfetamine (a type of medication that helps relieve nasal congestion). It is designed to provide temporary relief from nasal congestion caused by conditions such as the common cold, hay fever, or upper respiratory allergies.
By inhaling the vapor, you can help clear your nasal passages, making it easier to breathe when you're feeling congested. This product is a convenient option for those seeking quick relief from nasal discomfort.
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 helps to clear up your nasal passages, making it easier for you to breathe comfortably.
Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this medication. This makes it a safer option for those who may be pregnant or planning to become pregnant.
Dosage and Administration
When using this product, you will receive a dose of levmetamfetamine, which is a medication that helps relieve nasal congestion. Each 800 mL of air you inhale contains between 0.04 to 0.150 mg of this active ingredient. For adults and children aged 12 and older, you should take 2 inhalations in each nostril. If you are supervising a child aged 6 to under 12, they should take 1 inhalation in each nostril.
It's important to remember that you should not use this product more often than every 2 hours. If you have a child under 6 years old, consult a doctor before use, and do not use this product at all for children under 2 years of age. 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 never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, avoid using this medication for more than 7 days. Following these guidelines will help you use the medication effectively and minimize any potential risks.
Side Effects
You may experience some temporary side effects, such as burning, stinging, sneezing, or increased nasal discharge. If you use the product frequently or for a long time, you might find that nasal congestion returns or worsens. It's important to stop using the product and consult a doctor if your symptoms persist.
If you are pregnant or breastfeeding, please consult 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. Exceeding the dosage can lead to unwanted side effects, such as temporary burning, stinging, sneezing, or increased nasal discharge. You should not use this product for more than 7 days, as frequent or prolonged use may cause your nasal congestion to return or worsen. Additionally, sharing this container with others can spread infections, so it's best to keep it for your personal use only.
If your symptoms persist, stop using the medication and consult your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this product to ensure it's safe for you.
Overdose
If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.
Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.
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
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 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 (issues with liver function).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.
Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.
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 EQUALINE®?
EQUALINE® is a nasal decongestant vapor inhaler that provides temporary relief of nasal congestion.
What is the active ingredient in EQUALINE®?
The active ingredient in EQUALINE® is levmetamfetamine, which acts as a nasal decongestant.
What conditions does EQUALINE® help relieve?
EQUALINE® is indicated for temporary relief of nasal congestion due to the common cold, hay fever, or upper respiratory allergies.
How should I use EQUALINE®?
Adults and children 12 years and older should take 2 inhalations in each nostril, while children aged 6 to under 12 should take 1 inhalation in each nostril with adult supervision.
Are there any age restrictions for using EQUALINE®?
Children under 6 years of age should ask a doctor before use, and it is not recommended for children under 2 years of age.
What are the side effects of EQUALINE®?
Temporary burning, stinging, sneezing, or increased nasal discharge may occur. Frequent or prolonged use may cause nasal congestion to recur or worsen.
What should I do if symptoms persist?
You should stop using EQUALINE® and ask a doctor if symptoms persist.
Can I use EQUALINE® if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using EQUALINE®.
How long can I use EQUALINE®?
Do not use EQUALINE® for more than 7 days and do not exceed the recommended dosage.
What should I do if I accidentally swallow EQUALINE®?
If swallowed, get medical help or contact a Poison Control Center right away.
How should I store EQUALINE®?
Store EQUALINE® tightly closed at a temperature between 59°-86° F (15°-30° C).
Packaging Info
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine). 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
The product is identified by NDC 41163-031-01 and is comparable to the original Vicks® Vapoinhaler®. It contains levmetamfetamine as the active ingredient, serving as a nasal decongestant. This inhaler provides temporary relief of nasal congestion associated with colds, hay fever, and upper respiratory allergies. The net weight of the product 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 per 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, under adult supervision, the dosage is 1 inhalation in each nostril.
It is important to note that the product should not be used more frequently than every 2 hours. For children under 6 years of age, consultation with a healthcare professional is advised prior to use. The product is contraindicated in children under 2 years of age.
Contraindications
There are no specific contraindications identified for this product. However, it is essential to adhere to the following guidelines to ensure safe use:
Do not exceed the recommended dosage.
Do not use for more than 7 days.
Failure to comply with these instructions may lead to adverse effects or diminished efficacy.
Warnings and Precautions
Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product to ensure patient safety and efficacy.
Dosage and Administration It is imperative that the recommended dosage is not exceeded. The product should only be used as directed, and it is advised not to use it for more than 7 consecutive days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.
Potential Side Effects Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge upon application. These effects are generally mild but should be monitored.
Infection Control To prevent the spread of infection, this container should not be used by more than one person.
Discontinuation of Use Patients should be instructed to stop using the product and consult a healthcare provider if symptoms persist.
Emergency Situations In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
Pregnancy and Breastfeeding For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to assess potential risks.
No specific laboratory tests are required for monitoring the use of this product; however, healthcare providers should remain vigilant for any adverse effects or complications that may arise during treatment.
Side Effects
Patients may experience temporary burning, stinging, sneezing, or increased nasal discharge following the use of the product. It is important to note that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.
Patients are advised to discontinue use and consult a healthcare professional if symptoms persist. Additionally, individuals who are pregnant or breastfeeding should seek guidance from a health professional prior to use.
To ensure safety, the product should 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 recommended.
Drug Interactions
There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.
Packaging & NDC
Below are the non-prescription pack sizes of Vapor Inhaler (levmetamfetamine). 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 physician before use. The product is contraindicated in children under 2 years of age.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.
Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.
Management procedures should include monitoring vital signs and providing supportive care as necessary. It is advisable to have the product's labeling and any relevant medical history available to assist healthcare providers in determining the appropriate course of action.
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 assessment of potential risks associated with the use of the compound in these contexts.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.
Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to emphasize that patients must not exceed the recommended dosage. They should be made aware that temporary burning, stinging, sneezing, or increased nasal discharge may occur during use.
Additionally, healthcare providers should caution patients that using this container by more than one person may lead to the spread of infection. It is important to inform patients that the product should not be used for more than 7 days and that it should only be used as directed. Frequent or prolonged use may result in the recurrence or worsening of nasal congestion, which should be clearly communicated to ensure safe and effective use.
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.