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Quality Choice

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Active ingredient
Phenylephrine Hydrochloride 1 g/100 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
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 2024
Label revision date
October 8, 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
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 2024
Label revision date
October 8, 2024
Manufacturer
CHAIN DRUG MARKETING ASSOCIATION
Registration number
M012
NDC root
83324-215
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Quality Choice Nasal Spray Phenylephrine HCl is a nasal spray designed to provide temporary relief from nasal congestion. It contains 1% phenylephrine hydrochloride, which works as a nasal decongestant. This medication is effective for alleviating congestion caused by common colds, hay fever, and upper respiratory allergies, helping to relieve symptoms such as nasal and sinus congestion, sinus pressure, and swollen nasal membranes.

If you're experiencing discomfort from nasal congestion, this product may help you breathe more easily. It's important to use it as directed to achieve the best results.

Uses

If you're dealing with nasal congestion from a 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, this medication does not have any known teratogenic effects, meaning it does not cause birth defects. You can use it with confidence for your nasal congestion needs.

Dosage and Administration

When using this medication, adults and children aged 12 years and older should spray 2 or 3 times into each nostril, but make sure not to do this more than once 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 proper guidance.

To use the spray correctly, keep your head in a normal, upright position. Insert the tip of the atomizer (the spray device) into your nostril, then squeeze the bottle firmly and quickly while inhaling. After each use, remember to wipe the nozzle clean to keep it hygienic and functioning well.

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 three days in a row, as prolonged use can lead to worsening nasal congestion. Always follow the directions provided and do not exceed the recommended dosage.

To avoid potential risks, make sure to use this medication only as directed. Misuse or overuse can lead to complications, so it's crucial to adhere to these guidelines for your health.

Side Effects

Using this product may lead to some side effects. You might experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, frequent or prolonged use could cause nasal congestion to come back or worsen. It's important to note that if the container is shared with others, there is a risk of spreading infections.

If your symptoms persist, you should stop using the product and consult a doctor for further advice.

Warnings and Precautions

Before using this product, 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. Always follow the directions carefully—do not exceed the recommended dose or use it for more than three days. Overuse can lead to worsening nasal congestion, and you may experience temporary discomfort like burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product can lead to the spread of infection.

If your symptoms do not improve, stop using the product and contact your doctor. In case of accidental swallowing, seek medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 considering this medication for your child, it's important to note that it is approved for use in adults and children aged 12 years and older. For this age group, the recommended dosage is 2 or 3 sprays in each nostril, which can be repeated every 4 hours as needed.

If your child is under 12 years old, you should consult a doctor before using this medication. This ensures that you receive the appropriate guidance and care tailored to your child's specific needs. Always prioritize safety and seek professional advice when it comes to medications for younger children.

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 consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to 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 discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 and safety of your product, it is important to store it at room temperature. This means keeping it in a place that is not too hot or 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. By taking these simple steps, you can help ensure that the product remains effective and safe for your needs.

Additional Information

You can use this medication through your nose, with adults and children aged 12 and older typically taking 2 or 3 sprays in each nostril every 4 hours. For children under 12, it's best to consult a doctor first. If you are pregnant or breastfeeding, make sure to talk to a healthcare professional before using this product.

Be aware that using this medication frequently or for a long time may lead to worsening nasal congestion. You might experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. It's important to keep the container away from others to prevent the spread of infection, and always store it out of reach of children. If the medication is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Quality Choice Nasal Spray Phenylephrine HCl used for?

It is used for the temporary relief of nasal congestion due to common cold, hay fever, and upper respiratory allergies.

How should I use Quality Choice Nasal Spray?

With your head in a normal, upright position, insert the atomizer tip into your nostril and squeeze the bottle while inhaling. Adults and children 12 years and over can use 2 or 3 sprays in each nostril every 4 hours.

Are there any side effects of using this nasal spray?

Temporary discomfort such as 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 the product and ask a doctor if your symptoms persist.

Is there any special advice for pregnant or breastfeeding women?

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

What precautions should I take before using this nasal spray?

Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

How should I store Quality Choice Nasal Spray?

Store the nasal spray at room temperature.

What should I do if I accidentally swallow the nasal spray?

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

Packaging Info

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

Packaging configurations for Quality Choice.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This nasal spray contains Phenylephrine Hydrochloride at a concentration of 1%. It is formulated as a nasal decongestant and is available in a 1 fluid ounce (30 mL) bottle. The product is distributed by CDMA, Inc., located in Novi, MI 48375. The National Drug Code (NDC) for this product is 83324-215-01. This product is not manufactured or distributed by Novartis Consumer Health, Inc., the owner of the registered trademark 4-Way® Fast Acting Nasal Spray. For inquiries, contact 800-935-2362 or visit www.qualitychoice.com.

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.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 2 to 3 sprays in each nostril, administered no more frequently than every 4 hours.

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

Administration should be performed with the patient's head in a normal, upright position. The atomizer tip should be inserted into the nostril, and the bottle should be squeezed with firm, quick pressure while the patient inhales. It is important to wipe the nozzle clean after each use to maintain hygiene and ensure proper function.

Contraindications

The product should not be used in excess of the recommended dosage or for a duration exceeding three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Adherence to the specified directions for use is essential to mitigate potential risks.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician 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.

When utilizing this product, it is imperative to adhere strictly to the recommended dosage. Patients should not exceed the directed use or utilize the product for more than three consecutive days. It is essential to use the product only as directed to avoid complications. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that if the container is used by multiple individuals, there is a risk of spreading infection.

Patients should be instructed to discontinue use and seek medical advice if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Frequent or prolonged use of this product may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, there is a risk that infection may spread if the container is used by more than one person.

Patients are advised to stop using the product and consult a doctor if symptoms persist.

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 Quality Choice (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Quality Choice.
Details

Pediatric Use

Pediatric patients aged 12 years and older may receive 2 or 3 sprays in each nostril, not to exceed every 4 hours. For children under 12 years of age, it is advised to consult a doctor before use.

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 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. 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 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and provide appropriate management based on the severity of symptoms presented.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to adhere to the following guidelines: do not exceed the recommended dosage, do not use the product for more than three days, and use it only as directed. Patients should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Additionally, they may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge.

Healthcare providers should inform patients that the risk of infection may increase if the container is used by more than one person. It is also important to ask patients about their medical history and advise them 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 assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

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

Clinicians should counsel patients on several important points: if pregnant or breastfeeding, they should seek advice from a health professional before use. Patients should be aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Temporary side effects such as burning, stinging, sneezing, or increased nasal discharge may occur. Additionally, to prevent the spread of infection, the container should not be shared among multiple users. It is crucial to keep the medication out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Quality Choice, 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 Quality Choice, 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

Last AI update:

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.