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Nafasolina
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- Active ingredient
- Naphazoline Hydrochloride 50 mg/100 mL
- Other brand names
- Dermfree Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Natuheal Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Natuheal Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Nazal (by Sato Pharmaceutical Co. , Ltd.)
- Sato Clear (by Sato Pharmaceutical Co. , Ltd.)
- Seacall Nasal Spray. (by Guangdong Quadrant Ecological Technology Co. , Ltd.)
- Serynth Fast Relief Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Serynth Fast Relief Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Skapemed Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Skapemed Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- View full label-group details →
- Dosage form
- Solution/ Drops
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- December 18, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Naphazoline Hydrochloride 50 mg/100 mL
- Other brand names
- Dermfree Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Dermfree Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Natuheal Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Natuheal Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Nazal (by Sato Pharmaceutical Co. , Ltd.)
- Sato Clear (by Sato Pharmaceutical Co. , Ltd.)
- Seacall Nasal Spray. (by Guangdong Quadrant Ecological Technology Co. , Ltd.)
- Serynth Fast Relief Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Serynth Fast Relief Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- Skapemed Original Nasal (by Jiangxi Hemei Pharmaceutical Co. , Ltd)
- Skapemed Original Nasal (by Jiangxi Yudexi Pharmaceutical Co. , Ltd)
- View full label-group details →
- Dosage form
- Solution/ Drops
- 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 2025
- Label revision date
- December 18, 2025
- Manufacturer
- Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals
- Registration number
- M012
- NDC root
- 12539-146
- 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
Naphazoline hydrochloride 0.05% is a type of nasal drop used to provide temporary relief from nasal congestion caused by conditions such as the common cold, hay fever, or sinusitis. When you use these drops, they work by helping to clear your nasal passages, making it easier for you to breathe.
This medication is specifically designed to relieve a stuffy nose, offering quick comfort when you're feeling congested. If you're dealing with nasal congestion, Naphazoline hydrochloride can be a helpful option to consider.
Uses
Naphazoline hydrochloride 0.05% nasal drops are designed to provide temporary relief from nasal congestion caused by conditions like the common cold, hay fever, or sinusitis. If you're dealing with a stuffy nose, these drops can help clear your nasal passages, making it easier for you to breathe.
Using these nasal drops can be a quick solution to alleviate discomfort from congestion, allowing you to feel more comfortable during your day.
Dosage and Administration
If you are an adult or a child aged 12 years and older, you can use this medication by placing 1 or 2 drops in each nostril. Make sure to wait at least 6 hours before using it again, as you should not use it more frequently than that.
It's important to note that this medication is not recommended for children under 12 years of age unless a doctor specifically advises it. Always follow your healthcare provider's instructions to ensure safe and effective use.
What to Avoid
You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or if you have stopped taking an MAOI within the last two weeks. Additionally, if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, consult your doctor before use. This product is not suitable for children under 12 years old, especially those with heart conditions or other serious health issues.
If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. You should also limit use to no more than three days, as prolonged use can worsen nasal congestion. Be careful to avoid contact with your eyes; if contact occurs, rinse your eyes thoroughly with water.
Side Effects
You may experience some temporary discomfort when using this product, such as burning, stinging, sneezing, or an increase in nasal discharge. It's important to note that sharing this product with others can lead to the spread of infection. If you use it frequently or for a long time, you might find that nasal congestion returns or worsens.
Additionally, you should avoid using this product if you have certain health conditions, including heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, unless your doctor advises otherwise. It is also not recommended for children under 12 years old, as it may cause sedation if swallowed. Be sure to keep the product away from your eyes while using it.
Warnings and Precautions
It's important to use this product only as directed and not exceed the recommended dosage. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Avoid using this product for more than 3 days, as prolonged use can worsen nasal congestion. If your symptoms persist after this period, please consult your doctor.
Before using this product, make sure you do not have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate unless your doctor has advised you otherwise. This product is not suitable for children under 12 years old, as it may cause sedation if swallowed. Always keep it out of reach of children, and in case of accidental overdose, seek medical help immediately or contact a Poison Control Center.
If you are pregnant or breastfeeding, consult a healthcare professional before use. Avoid contact with your eyes, and if contact occurs, rinse your eyes thoroughly with water. Additionally, do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If you are unsure about your medications, please check with a healthcare professional.
Overdose
It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme 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 right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.
Pregnancy Use
If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using this product. This ensures that you receive personalized advice and understand any potential risks associated with its use during this time. Your health and the health of your baby are the top priority, so always seek guidance from a qualified expert.
Lactation Use
If you are breastfeeding or pregnant, it’s important to talk to your healthcare professional before using this product. They can help you understand any potential risks and ensure that it’s safe for you and your baby. Always prioritize your health and your baby's well-being when considering any medication or treatment.
Pediatric Use
It's important to be cautious when considering this product for children. You should not give it to children under 12 years of age unless a doctor specifically advises you to do so. This is because the product can cause sedation (drowsiness) if swallowed, which can be risky for younger children.
Additionally, if your child has any pre-existing health conditions such as heart disease, high blood pressure, thyroid disease, or diabetes, you should consult a doctor before using this product. Always prioritize your child's safety and well-being by seeking professional guidance when it comes to their health.
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, it’s important to consult with a healthcare provider for personalized advice. 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 kidney function might affect the use of this medication.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.
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 may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.
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 the safety and effectiveness of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its quality. Always keep it out of reach of children to prevent accidental ingestion or misuse. Once you open the product, remember to discard it after use to ensure safety and avoid any potential contamination.
Additional Information
You should use this product as a nasal spray, applying 1 or 2 drops in each nostril no more than every 6 hours. It's important to stop using it after 3 days. If your symptoms continue, consult a doctor. Be aware that this product may cause temporary discomfort, such as burning or sneezing, and using it with others can spread infection.
Keep this product out of reach of children, and in case of accidental overdose, seek medical help immediately. Avoid using it if you have certain health conditions like heart disease or high blood pressure, unless directed by a doctor. It's not recommended for children under 12, as it may cause sedation if swallowed. If you're pregnant or breastfeeding, talk to a healthcare professional before use. Also, avoid contact with your eyes, and rinse thoroughly with water if contact occurs. Lastly, do not use this product if you are currently taking a monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks.
FAQ
What is Naphazoline hydrochloride 0.05% used for?
Naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.
How does Naphazoline hydrochloride work?
It temporarily relieves a stuffy nose and helps clear nasal passages.
What is the recommended dosage for adults and children over 12?
The recommended dosage is 1 or 2 drops in each nostril, not more often than every 6 hours.
Can children under 12 use this product?
No, do not give this product to children under 12 years of age unless directed by a doctor.
What should I avoid while using Naphazoline hydrochloride?
Avoid contact with the eyes, and do not use this product for more than 3 days.
What are the potential side effects?
You may experience temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
Who should not use Naphazoline hydrochloride?
Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement unless directed by a doctor.
What should I do if I accidentally overdose?
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Is it safe to use Naphazoline hydrochloride during pregnancy or breastfeeding?
If you are pregnant or breastfeeding, consult a healthcare professional before using this product.
Packaging Info
Below are the non-prescription pack sizes of Nafasolina (naphazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 50 mg/100 mL | ||
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 Nafasolina, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No description information is available for the specified drug.
Uses and Indications
Naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or sinusitis. This medication is effective in temporarily relieving a stuffy nose and helps to clear nasal passages.
Limitations of Use: Naphazoline hydrochloride nasal drops are intended for short-term use only. Prolonged use may lead to rebound congestion.
Dosage and Administration
For adults and children aged 12 years and over, the recommended dosage is 1 or 2 drops in each nostril, administered no more frequently than every 6 hours.
Administration should be performed with care to ensure proper delivery of the drops into the nasal passages.
It is important to note that this medication should not be administered to children under 12 years of age unless specifically directed by a healthcare professional.
Contraindications
Use of this product is contraindicated in the following situations:
Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks, due to the risk of serious interactions.
Individuals with heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to prostate enlargement should not use this product unless directed by a healthcare professional, as these conditions may exacerbate potential adverse effects.
This product is contraindicated in children under 12 years of age due to the risk of sedation if ingested. Additionally, it should not be used in children with heart disease, high blood pressure, thyroid disease, or diabetes unless specifically directed by a healthcare provider.
Consultation with a healthcare professional is advised for pregnant or breastfeeding individuals prior to use.
The product should not be used for more than three days, as prolonged use may lead to worsening nasal congestion.
Avoid contact with the eyes; in the event of contact, rinse thoroughly with water.
Warnings and Precautions
The recommended dosage of this product must not be exceeded to ensure safety and efficacy. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that sharing this container with others may facilitate the spread of infection.
This product should not be used for more than three consecutive days. It is essential to adhere strictly to the directions provided, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Should symptoms persist beyond this period, consultation with a healthcare professional is advised.
Individuals with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to prostate enlargement should refrain from using this product unless directed by a physician. Additionally, this product is contraindicated in children under 12 years of age due to the risk of sedation if ingested.
Care should be taken to avoid contact with the eyes while using this product. In the event of accidental contact, it is recommended to rinse the eyes thoroughly with water. This product must be kept out of reach of children, and in cases of accidental overdose, immediate medical assistance or contact with a Poison Control Center is necessary.
Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to using this product. Furthermore, it is contraindicated for use in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications. If there is any uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare provider is recommended.
This product is intended solely for nasal use. Users are advised to discontinue use after three days and to consult a doctor if symptoms persist.
Side Effects
Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that the use of this container by more than one person may lead to the spread of infection. Additionally, frequent or prolonged use of the product may result in the recurrence or worsening of nasal congestion.
Patients with certain pre-existing conditions should exercise caution. This product is contraindicated in individuals with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, unless directed by a healthcare professional. Furthermore, the product should not be used in children under 12 years of age, as ingestion may lead to sedation.
Care should also be taken to avoid contact with the eyes while using this product.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Nafasolina (naphazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 50 mg/100 mL | ||
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 under 12 years of age should not be given this product unless specifically directed by a healthcare professional. The use of this product in this age group is contraindicated due to the potential risk of sedation if swallowed.
Additionally, this product is not recommended for children with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, or diabetes unless advised by a physician. Caution is advised when considering treatment in these populations.
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 potential 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 product. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this product in these populations.
Lactation
Lactating mothers are advised to consult a healthcare professional prior to using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended for lactating mothers.
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
There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.
In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.
Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for additional guidance on the management of potential overdosage scenarios. It is essential to document any incidents of overdosage and report them to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.
Nonclinical Toxicology
There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology studies. Additionally, no data has been provided concerning animal pharmacology and toxicology.
Postmarketing Experience
Postmarketing experience has revealed that the use of naphazoline hydrochloride may be associated with temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. In children under 12 years of age, ingestion of the product may result in sedation.
Patient Counseling
Healthcare providers should advise patients to keep this product out of reach of children. In the event of an accidental overdose, patients should seek medical help or contact a Poison Control Center immediately.
Patients should be informed to discontinue use of this product after 3 days. If symptoms persist beyond this period, they should stop using the product and consult a healthcare professional.
For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product. Additionally, patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should seek guidance from a healthcare professional prior to use.
Patients should be instructed not to use this product for more than 3 days and to use it only as directed. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. If symptoms persist, patients should consult a doctor.
It is important to inform patients that this product should not be used by individuals with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland unless directed by a healthcare professional. Furthermore, this product is not recommended for children under 12 years of age, as it may cause sedation if ingested. In children with heart disease, high blood pressure, thyroid disease, or diabetes, the product should only be used if directed by a doctor.
Patients should be reminded that this product is intended for nasal use only. They should avoid contact with the eyes, and in the event of contact, they should rinse their eyes thoroughly with water.
Storage and Handling
The product is supplied in packaging that ensures its integrity and safety. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its efficacy. It is essential to protect the product from light exposure to prevent degradation. Additionally, the product must be kept out of reach of children to ensure safety. Once opened, the product should be discarded to avoid any potential risks associated with prolonged use.
Additional Clinical Information
The product is administered nasally, with a recommended dosage of 1 or 2 drops in each nostril for adults and children aged 12 years and older, not to exceed every 6 hours. Clinicians should advise patients to discontinue use after 3 days and to consult a doctor if symptoms persist.
Patients should be counseled to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center in the event of an accidental overdose. Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur. The product should not be used by individuals with heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties without medical guidance. It is contraindicated in children under 12 years due to potential sedation if ingested. Patients should avoid contact with eyes and consult a healthcare professional if pregnant or breastfeeding. Additionally, the product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such treatment. The use of this container by multiple individuals may pose a risk of infection.
Drug Information (PDF)
This file contains official product information for Nafasolina, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.