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Extra Strength Nasal

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Active ingredient
Phenylephrine Hydrochloride 1 g/100 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Spray
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
August 21, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 1 g/100 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Spray
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 2020
Label revision date
August 21, 2024
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
69842-443
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Extra Strength Nasal Spray is a nasal decongestant that contains 1.0% phenylephrine hydrochloride. It is designed to provide fast relief from nasal congestion caused by the common cold, hay fever, and upper respiratory allergies (allergic rhinitis). This non-drowsy formulation works by temporarily shrinking swollen membranes in your nasal passages, helping you breathe more freely.

In addition to relieving nasal congestion, this spray also helps alleviate sinus congestion and pressure, making it easier for you to feel comfortable and breathe normally. You can use it every four hours as needed for effective relief.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or upper respiratory allergies (also known as allergic rhinitis), this medication can help provide temporary relief. It works by shrinking swollen membranes in your nasal passages, making it easier for you to breathe.

Additionally, it can alleviate sinus congestion and pressure, allowing for a more comfortable breathing experience. With this medication, you can expect to restore freer breathing through your nose, helping you feel more at ease.

Dosage and Administration

When using the spray, make sure to squeeze the bottle quickly and firmly to release the medication effectively. If you are an adult or a child aged 12 years and older, you can use 2 or 3 sprays in each nostril, but remember not to do this more often than every 4 hours.

If the user is a child under 12 years old, it’s important to consult a doctor before using the spray to ensure it’s safe and appropriate for them. Always follow these guidelines to ensure you are using the medication correctly and safely.

What to Avoid

If you have ever experienced an allergic reaction to this product or any of its ingredients, you should not use it. It's important to follow the usage instructions carefully: do not exceed the recommended dose and do not use the product for more than three days. Always use it exactly as directed to ensure your safety and well-being.

Remember, misuse or overuse of this product can lead to serious issues, including dependence (a condition where your body becomes reliant on a substance). Prioritize your health by adhering to these guidelines.

Side Effects

If you have ever experienced an allergic reaction to this product or any of its ingredients, it is important to avoid using it. You should also stop using the product and consult a doctor if your symptoms persist.

Before using this product, consider speaking with your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Your health and safety are paramount, so it's best to ensure that this product is appropriate for you.

Warnings and Precautions

If you have ever had an allergic reaction to this product or any of its ingredients, you should not use it. Before starting this medication, it’s important to consult your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. If your symptoms continue or worsen while using this product, stop taking it and reach out to your doctor for further guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and 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

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 2 or 3 sprays in each nostril, but this should not be done more frequently than every 4 hours. Always follow these guidelines to ensure the safety and well-being of your child.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, it is important to store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

You can use this medication through your nose (nasal administration). For adults and children aged 12 and older, the recommended dose is 2 or 3 sprays in each nostril, but you should not use it more often than every 4 hours. If you are giving this medication to a child under 12 years old, it's important to consult a doctor first for guidance.

FAQ

What is Extra Strength Nasal Spray used for?

Extra Strength Nasal Spray is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies.

How does Extra Strength Nasal Spray work?

It works by shrinking swollen membranes in the nasal passages, which facilitates freer breathing and temporarily relieves sinus congestion and pressure.

How often can I use Extra Strength Nasal Spray?

You can use it every 4 hours, but do not exceed the recommended dosage.

What are the instructions for using Extra Strength Nasal Spray?

To use, squeeze the bottle quickly and firmly. Adults and children 12 years and older should use 2 or 3 sprays in each nostril, not more often than every 4 hours.

Are there any warnings associated with Extra Strength Nasal Spray?

Yes, do not use it if you have ever had an allergic reaction to this product or its ingredients. Also, consult a doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate.

What should I do if symptoms persist?

If symptoms persist, stop using the product and ask a doctor for further advice.

Can I use Extra Strength Nasal Spray if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What should I do if I accidentally swallow Extra Strength Nasal Spray?

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Extra Strength Nasal Spray?

Store the spray at room temperature and keep the carton for future reference on full labeling.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Nasal (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Nasal.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Nasal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Phenylephrine hydrochloride is a nasal decongestant formulated at a concentration of 1.0%. It is indicated for the relief of sinus congestion and pressure associated with colds and allergies. This formulation is designed to provide fast relief without causing drowsiness. The recommended dosing interval is every 4 hours as needed.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and upper respiratory allergies (allergic rhinitis). It also provides temporary relief from sinus congestion and pressure, facilitating freer breathing through the nasal passages by shrinking swollen membranes.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the administration of the medication, healthcare professionals should instruct patients to spray by squeezing the bottle quickly and firmly.

For adults and children aged 12 years and older, the recommended dosage is 2 to 3 sprays in each nostril, with a maximum frequency of every 4 hours.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with a history of allergic reactions to this product or any of its ingredients.

Additionally, the product should not be used for more than three consecutive days and must be used strictly as directed to avoid potential adverse effects.

Warnings and Precautions

Patients with a history of allergic reactions to this product or any of its ingredients should not use it.

Healthcare professionals are advised to exercise caution and recommend that patients consult a physician prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult their healthcare provider if symptoms persist.

Side Effects

Patients should be aware of the potential for serious allergic reactions to this product or any of its ingredients. Individuals with a history of such reactions are advised to avoid use.

In clinical practice, it is recommended that patients stop using the product and consult a healthcare professional if symptoms persist.

Additionally, patients should seek medical advice prior to using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These considerations are important to ensure the safe use of the product and to mitigate any potential adverse reactions.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Nasal (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Nasal.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 4 hours.

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 elderly patients closely for any potential adverse effects or changes in therapeutic response, given the lack of detailed guidance in the prescribing information. Individualized assessment and clinical judgment are recommended to ensure the safe and effective use of this medication in the geriatric 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 available data 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 lack of information 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult poison control centers for additional guidance on management strategies.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, and an increase in nasal discharge. No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. Additionally, temporary discomfort has been reported, which may include symptoms such as burning, stinging, sneezing, and an increase in nasal discharge. These events have been documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be informed to disclose any history of allergic reactions to this product or any of its ingredients prior to use.

It is important to instruct patients to stop using the product and consult a doctor if symptoms persist. They should be cautioned against exceeding the recommended dosage and advised not to use the product for more than three days, emphasizing the necessity of adhering to the directed usage.

Patients should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. They should also be informed that temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, and an increase in nasal discharge.

Healthcare providers should highlight that the use of this container by more than one person may facilitate the spread of infection. Additionally, patients should be encouraged to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be used more frequently than every 4 hours. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Extra Strength Nasal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (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 Extra Strength Nasal, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory 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.

Learn more in our Editorial Policy

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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.