Quality Choice

Description

NDC# 63868-697-30. This product is a nasal spray formulation containing 1% phenylephrine hydrochloride, indicated as a nasal decongestant. The dosage form is 1 fluid ounce (30 mL). It is distributed by C.D.M.A. Inc., located at 43157 W 9 Mile Rd, Novi, MI 48375. For inquiries, contact 248-449-9300 or visit www.qualitychoice.com. This product is not manufactured or distributed by Novartis Consumer Health, Inc., the owner of the registered trademark 4-Way® Fast Acting Nasal Spray.

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 drops 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 prevent contamination.

Contraindications

Use is contraindicated in the following situations:

• Do not exceed the recommended dosage or duration of use. Prolonged use beyond 3 days may lead to a recurrence or worsening of nasal congestion.

• The product should not be used by multiple individuals, as this may facilitate the spread of infection.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to 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. These conditions may increase the risk of adverse effects or complications.

When administering this product, it is crucial to adhere to the recommended dosage. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Additionally, users may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. It is also important to note that sharing this container with others may facilitate the spread of infection.

Healthcare providers should instruct patients to discontinue use and seek medical advice if symptoms persist.

In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is essential to mitigate potential health risks associated with swallowing the product.

Side Effects

Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

It is important to note that frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion.

Patients are advised to discontinue use and consult a healthcare professional 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.

Pediatric Use

Pediatric patients aged 12 years and older may use 2 or 3 drops in each nostril, not to be administered more frequently than 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 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this 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 drug. 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 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. It is recommended that healthcare providers assess the patient's condition and consider the necessity for supportive care or specific treatment protocols based on the severity of symptoms presented.

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, or an increase in nasal discharge.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, may occur following use. Additionally, it has been reported that the use of this container by more than one person may facilitate the spread of infection.

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. It is important to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. Patients should be informed that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. Healthcare providers should emphasize that the use of this container by more than one person may increase the risk of spreading infection.

Additionally, patients should be encouraged to consult with their healthcare provider before using the 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. This precaution is essential to ensure the safe and effective use of the product.

Storage and Handling

The product is supplied in a container that is filled to the proper level to ensure optimal spray action. It should be stored at room temperature to maintain its efficacy and performance. Special handling requirements are not specified; however, it is advisable to handle the container with care to preserve its integrity.

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 drops 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 to seek advice from a health professional if they are pregnant or breastfeeding. It is important to note that sharing the container with others may lead to the spread of infection. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately 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)