Oxymetazoline hydrochloride

Description

NDC 69618-050-51 identifies a 12-hour decongestant nasal spray manufactured by Reliabel-1 Laboratories. The active ingredient is oxymetazoline hydrochloride, which provides rapid and powerful relief from nasal congestion. This formulation is delivered in a pump mist anti-drip system, ensuring effective application. Each bottle contains 1 fluid ounce (30 mL) of the solution, designed for extended 12-hour relief from nasal congestion.

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, and is effective in shrinking swollen nasal membranes.

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

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered 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 a 24-hour period.

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

Prior to administration, the bottle should be shaken well. To open the bottle, the cap must be rotated to align the marks, followed by squeezing the cap on both sides in a counter-clockwise direction to remove it. For proper spraying technique, 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, and the cap should be snapped back onto the bottle to ensure proper storage.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to keep the product out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. Additionally, if symptoms persist, discontinue use and consult a healthcare professional.

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 of the product for more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is crucial to inform patients that sharing this container with others may facilitate the spread of infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare provider if symptoms persist.

Side Effects

Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or an increased nasal discharge. These reactions are generally mild and self-limiting.

It is important to note that the use of this container by more than one person may lead to the spread of infection.

Patients are advised to stop use and consult a doctor if symptoms persist, as this may indicate a need for further evaluation or alternative treatment options.

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 Oxymethazoline Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 2 or 3 sprays in each nostril, administered with adult supervision. Dosing should not occur more frequently than every 10-12 hours, and the total daily dosage must not exceed 2 doses within a 24-hour period.

For children under 6 years of age, it is advised to consult a physician before 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 currently no available data on the excretion of this drug 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several events reported voluntarily or through surveillance programs. Temporary discomfort, including symptoms such as burning, stinging, sneezing, or increased nasal discharge, may occur following use. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. It has also been noted that using 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. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if symptoms persist. It is also important for healthcare providers to encourage patients to seek medical advice before using the medication 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 packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a temperature range of 20º to 25º C (68º to 77º F) to ensure its stability and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, which may be necessary for proper usage and compliance. Special handling requirements are not specified; however, adherence to the recommended storage conditions is crucial for maintaining product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)