Quality Choicel

Description

Quality Choice Nasal Mist Extra Moisture is a nasal solution containing 0.05% oxymetazoline hydrochloride as the active ingredient. This formulation is designed to provide fast and powerful relief from nasal congestion associated with colds and allergies. The product features extra moisturizing properties that help rehydrate dry nasal passages. It utilizes a no-drip pump mechanism, ensuring that the mist does not drip from the nose or down the throat. Each bottle contains 1 fluid ounce (30 mL) of the solution. The product is distributed by C.D.M.A., Inc., located in Novi, MI, and is comparable to the active ingredient found in Afrin® No Drip Extra Moisturizing Pump Mist. The National Drug Code (NDC) for this product is 83324-211-01. For further information, the product's website is www.qualitychoice.comwww.qualitychoice.com, and customer service inquiries can be directed to 800-935-2362.

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 drug 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 the total number of doses must not exceed 2 in any 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

To administer the medication, the following steps should be observed: Shake the bottle well before use. Remove the cap by pushing down on the cup while turning it counter-clockwise. Remove the clip located under the rim. Prior to the initial use, prime the metered pump by firmly depressing it several times. To spray, hold the bottle with the thumb at the base and the nozzle rim positioned between the first and second fingers. Insert the nozzle into the nostril without tilting the head. Fully depress the rim with a firm, even stroke while sniffing deeply. After use, wipe the nozzle clean, replace the clip under the rim, and securely cap the bottle.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product not be used in excess of the directed dosage or for a duration exceeding three days, as prolonged use may lead to a recurrence or worsening of nasal congestion. Additionally, the use of this container by multiple individuals is discouraged due to the potential risk of infection transmission.

Warnings and Precautions

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 for guidance.

Patients should discontinue use and consult a healthcare provider if symptoms persist. This precaution is essential to ensure appropriate evaluation and management of the patient's condition.

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 medication.

These precautions are essential to ensure the safe and effective use of the product, minimizing the risk of adverse effects in susceptible individuals.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Quality Choicel (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. Adult supervision is advised for this age group during administration.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in these patients regularly to assess their liver status and adjust treatment as necessary. Caution should be exercised when administering this medication to individuals with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

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 relevant 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. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. They should be cautioned 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.

Additionally, healthcare providers should emphasize that this product should not be shared among individuals, as doing so 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 note that the product should not be used if the printed seal over the cap is broken or missing.

For optimal preservation, the product must be stored at room temperature. Care should be taken to maintain the integrity of the packaging and to adhere to the specified storage conditions to ensure product efficacy and safety.

Additional Clinical Information

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

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

Drug Information (PDF)

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

View product document (PDF)