Oxymetazoline hydrochloride

Description

This product is identified by the code 51945-4 and is associated with the effective date of December 26, 2024. The principal display panel includes visual representations, specifically an image labeled "label.jpg" and another labeled "carton.jpg," both in JPEG format. These images serve to provide a visual reference for the product's packaging.

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

Prior to use, the bottle must be shaken well. To open the bottle, the cap should be rotated to align the marks, followed by squeezing the cap on both sides and turning it counter-clockwise to remove. 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 must be wiped clean, and the cap should be snapped back onto the bottle to ensure proper storage.

Contraindications

There are no explicit contraindications identified for this product. However, the following precautions should be observed:

• Use should not exceed the directed dosage.

• The product should not be used for more than three consecutive days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

• The use of this container by multiple individuals may pose a risk of infection transmission.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and require careful consideration before initiating treatment.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center or seek emergency medical help without delay.

If symptoms persist despite use, it is imperative to discontinue the medication and consult a healthcare provider. Ongoing symptoms may indicate a need for reevaluation of the treatment plan or further investigation into the underlying condition.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a history of heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. This precaution is essential to ensure the safety and well-being of individuals with underlying health conditions.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of 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

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 maternal and fetal safety.

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 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 clinical trials for this medication. Consequently, there is no information available 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.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

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

It is important to communicate that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, inform patients that sharing this container with others may increase the risk of spreading infection.

Patients should be advised to stop using the medication and consult a doctor if their symptoms persist. Furthermore, healthcare providers should encourage patients to seek medical advice before using the medication if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled temperature between 20° and 25°C (68° and 77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, ensuring that all necessary details are readily accessible for proper handling and administration.

Additional Clinical Information

The route of administration for the medication is nasal. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)