Theraflu

Description

Oxymetazoline HCl is a nasal decongestant formulated as a cooling nasal mist. Each unit contains 0.34 fluid ounces (10 mL) of the product, designed for ease of use with a one-thumb push button mechanism. The device features a shorter nozzle that delivers an ultra-fine mist for effective application.

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

Adults and children aged 6 years to under 12 years, under adult supervision, are advised to administer 2 sprays in each nostril, not to be repeated more frequently than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is recommended prior to use.

Prior to administration, the product should be shaken well. To prepare the device for use, the cap must be removed by pressing the grooves on each side and turning to lift the cap. Before the initial use, the sprayer should be primed by pressing the button several times. For effective delivery, the sprayer tip should be inserted into the nostril, and the button should be firmly pressed with the thumb while simultaneously sniffing deeply. It is important to remain in an upright position during the spraying process. 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 directions provided.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product. Prior to use, patients should be advised to consult a physician 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 use the product for more than three consecutive days, as prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Should symptoms persist beyond this duration, a consultation with a healthcare provider is warranted. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users 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. If symptoms continue despite adherence to the recommended usage guidelines, patients are advised to discontinue use and consult their healthcare provider for further evaluation.

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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Theraflu (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may use the medication with adult supervision, receiving 2 sprays in each nostril no more frequently than every 10 to 12 hours. The maximum dosage should not exceed 2 doses within a 24-hour period. For children under 6 years of age, it is advised to consult a doctor prior to use.

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 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, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 noted 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 this product out of reach of children. Instruct patients that if the product is swallowed, they 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. When using this product, it is essential to not exceed the recommended dosage and to limit use to no more than three days. Patients should use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. They should also be made aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use.

Additionally, healthcare providers should caution patients that the use of this container by more than one person may spread infection. It is important to ask patients about their medical history and advise them to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a configuration that includes specific packaging requirements. It is essential to store the product at a temperature not exceeding 25°C (77°F) to maintain its efficacy.

During use, the product should be kept in an upright position while spraying to ensure proper application. After each use, it is important to wipe the sprayer tip clean and securely replace the cap to prevent contamination and maintain functionality.

Healthcare professionals should be aware that the product should not be used if a red unlock icon is visible on either end of the carton prior to first opening, or if the red unlock icon is absent after the product has been opened. These indicators are crucial for ensuring the integrity and safety of the product.

Additional Clinical Information

Patients aged 6 years to under 12 years, under adult supervision, should administer 2 sprays in each nostril, not 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). Patients should not use the product 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)