Theraflu

Description

Theraflu Severe Congestion Relief Nasal Mist is a nasal decongestant formulation containing oxymetazoline hydrochloride as the active ingredient. This product is designed to provide relief from nasal congestion for up to 12 hours. It is packaged in a 0.34 fluid ounce (10 mL) volume. The formulation features an ultra-fine mist delivery system, which allows for rapid unblocking of nasal passages. The device is engineered for user comfort, incorporating a shorter nozzle and a one-thumb push button mechanism for ease of use.

Uses and Indications

This drug is indicated for the temporary relief of nasal decongestion associated with the common cold, hay fever, and other upper respiratory allergies (allergic rhinitis). It provides symptomatic relief from a stuffy nose and aids in clearing nasal passages by shrinking swollen membranes. Additionally, this drug temporarily restores freer breathing through the nose and helps decongest sinus openings and passages, alleviating sinus congestion and pressure.

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

Dosage and Administration

For adults and children aged 6 years to under 12 years, the recommended dosage is 2 sprays in each nostril, administered not more frequently than every 10 to 12 hours. 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 doctor prior to administration.

Prior to use, the product must be shaken well. To remove the cap, the user should press the grooves on each side and turn to lift the cap. Before the initial use, the sprayer should be primed by pressing the button several times. For administration, the user should insert the sprayer tip into the nostril, firmly press the button with the thumb, and sniff deeply while maintaining an upright position. After use, the sprayer tip should be wiped clean, and the cap should be securely replaced.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or utilize it for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. It is essential to adhere strictly to the directed usage guidelines.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. Prior to use, it is imperative to consult a physician if the patient has a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

When administering this product, it is essential to adhere strictly to the recommended dosage guidelines. Patients should not exceed the advised dosage or use the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Should symptoms persist beyond the recommended duration, a consultation with a healthcare provider is warranted.

Patients 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 product among multiple users may pose a risk of infection transmission.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if symptoms do not improve. In cases of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control center should be contacted without delay.

Side Effects

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

If symptoms persist, patients are advised to discontinue use and consult a healthcare professional for further evaluation and guidance.

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 Theraflu (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may receive 2 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. For children under 6 years of age, consultation with a doctor is advised prior to 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 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of their condition, as reduced kidney function may influence the pharmacokinetics and overall safety of the treatment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided from animal pharmacology and toxicology studies.

Postmarketing Experience

Postmarketing experience has indicated that temporary discomfort may occur following the use of the product. Reported events include sensations of burning and stinging, sneezing, and an increase in nasal discharge. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control center immediately.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. It is important to emphasize that while using this product, patients must not exceed the recommended dosage and should not use it for more than three days. They should use the product only as directed, as 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 that the use of this container by more than one person may increase the risk of spreading infection.

Before using the product, patients should be encouraged to consult a doctor 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 requires careful handling to maintain its integrity. It should be stored at a temperature not exceeding 25°C (77°F) to ensure optimal performance.

During use, the product must remain upright while spraying to prevent leakage and ensure proper application. After each use, it is essential to wipe the sprayer tip clean and securely replace the cap to protect the contents from contamination and maintain functionality.

Additional Clinical Information

Patients aged 6 years to under 12 years should receive 2 sprays in each nostril, administered no 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, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to read all warnings and directions on the carton before use and to retain the carton for future reference. It is important to adhere to the directed dosage and to avoid storage above 25°C (77°F). Additionally, the product should not be used if the red unlock icon is visible on either end of the carton before first opening or if it is absent after opening.

Drug Information (PDF)

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

View product document (PDF)