Quality Choice

Description

Quality Choice is a nasal solution containing 0.05% oxymetazoline hydrochloride as the active ingredient. This formulation is indicated as an original decongestant for the relief of nasal congestion associated with colds and allergies. The product is characterized by its maximum strength and a no-drip feature, ensuring that it does not drip from the nose or down the throat. Each bottle contains 1 fluid ounce (30 mL) of the solution. Quality Choice is distributed by C.D.M.A., Inc., located in Novi, MI 48375, and is backed by a 100% quality control satisfaction guarantee. For further information, visit www.qualitychoice.com or contact customer service at 800-935-2362. This product is not manufactured or distributed by Bayer Healthcare LLC, the distributor of Afrin® No Drip Original Pump Mist.

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. It also provides temporary relief from sinus congestion and pressure. Additionally, this medication acts to shrink swollen nasal membranes, facilitating easier breathing.

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

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period.

For children under 6 years of age, it is advised to consult a physician before administration.

To prepare the medication for use, the bottle should be shaken well prior to each use. The cap should be removed by pushing down while turning it counter-clockwise. The clip located under the rim must be removed. Before the initial use, the metered pump should be primed by firmly depressing the pump several times.

For administration, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The rim should be fully depressed with a firm, even stroke while the patient sniffs deeply. After use, the nozzle should be wiped clean, the clip replaced under the rim, and the cap secured.

Contraindications

Use is contraindicated in the following situations:

• Use is not recommended for more than the directed dosage or for a duration exceeding 3 days, as prolonged use may lead to worsening nasal congestion.

• The product should not be used by multiple individuals from the same container to prevent the risk of infection transmission.

Warnings and Precautions

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

General precautions must be strictly adhered to in order to ensure safe usage. It is imperative that the product is not used in excess of the directed dosage. Additionally, the duration of use should not exceed three days, as prolonged or frequent application may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge.

To prevent the risk of infection, it is crucial that this container is not shared among multiple users.

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if symptoms persist. This precaution is essential to ensure appropriate management and to rule out any underlying conditions that may require further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical trials and postmarketing experiences, certain serious adverse reactions have been noted, necessitating caution in specific populations.

Patients are advised to stop use and consult a doctor if symptoms persist. Additionally, it is recommended that individuals with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland seek medical advice before using this product.

These precautions are essential to ensure the safe use of the medication and to mitigate the risk of adverse effects in susceptible individuals.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period, and adult supervision is advised during administration.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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 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 no specific data available regarding the excretion of this medication in 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 may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to assess creatinine clearance to determine the appropriate dosing regimen for these patients. Regular monitoring of renal function is advised, with renal function tests performed prior to initiation of treatment and periodically throughout the course of therapy.

Special caution is warranted in patients with severe renal impairment, as reduced doses may be required for those with moderate to severe renal impairment. Regular assessment of renal function will help ensure safe and effective use of the medication in this population.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating careful consideration in their treatment regimen. It is essential that these patients are monitored closely for any adverse effects that may arise due to their compromised liver function.

For patients with moderate to severe hepatic impairment, dosage adjustments may be required to ensure safety and efficacy. A reduced dose may be necessary for those exhibiting significant liver dysfunction.

Prior to initiating treatment and throughout the course of therapy, liver function tests should be conducted to assess the patient's liver status and guide appropriate management. Regular monitoring will help in identifying any potential complications early and adjusting the treatment plan as needed.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

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 the use of the product. Additionally, it has been reported that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

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 instructed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is important to emphasize that patients should not exceed the recommended dosage and should not use it for more than three days. They should be informed that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge.

Healthcare providers should also caution patients against sharing the container with others, as this may facilitate the spread of infection.

Before initiating use, patients should be encouraged to consult with their healthcare provider 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 a configuration that ensures tamper evidence. It is essential to inspect the printed seal over the cap; the product should not be used if the seal is torn or missing.

For optimal storage, the product must be kept at room temperature. Proper handling and storage conditions are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours, with a maximum of 2 doses in any 24-hour period. For children under 6 years of age, it is advised to consult a doctor before use.

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. Patients should discontinue use and consult a doctor if symptoms persist.

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)