Children Afrin Extra Moisturizing Stuffy Nose Pump Mist

Description

No description information is available.

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

For children aged 2 to under 6 years, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is essential to adhere to the recommended amount and not exceed 2 doses within a 24-hour period.

For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

To administer the medication, the following steps should be followed:

1. Shake the bottle well before use.

2. Hold the white tabs and press the grooved area of the cap firmly while turning it counterclockwise.

3. Prior to the first use, prime the metered pump by firmly depressing it up to 10 times.

4. To spray, hold the bottle with the thumb at the base and the nozzle positioned between the first and second fingers.

5. Without tilting the head, insert the nozzle into the nostril.

6. Fully depress the rim with a firm, even stroke to deliver the spray.

7. After use, wipe the nozzle clean and securely replace the cap.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately, or contact a Poison Control Center for further guidance.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician prior to using this product if they or their child have any of the following conditions: heart disease, high blood pressure, thyroid disease, or diabetes.

When administering this product, it is imperative to adhere strictly to the recommended dosage. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Additionally, users 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 container with others may pose a risk of spreading infection.

Patients should be instructed to discontinue use and contact their healthcare provider if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of several important warnings and potential adverse reactions associated with the use of this product. Prior to use, it is advised that individuals consult a healthcare professional if they have a history of heart disease, high blood pressure, thyroid disease, or diabetes.

During the use of this product, it is crucial to adhere strictly to the recommended dosage and duration. Patients should not exceed the directed use or utilize the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Common temporary discomforts reported by participants may include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users may pose a risk of spreading infection.

Patients are advised to discontinue use and seek medical advice if symptoms persist. Furthermore, this product should be kept out of reach of children, and in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Children Afrin Extra Moisturizing Stuffy Nose Pump Mist (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to under 6 years may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is essential to adhere to the recommended dosage and not exceed 2 doses within a 24-hour period. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

Healthcare professionals should be aware of specific warnings associated with this medication. Parents or guardians should seek medical advice before administering the product if the child has a history of heart disease, high blood pressure, thyroid disease, or diabetes.

Additionally, it is crucial to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for women who are pregnant. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for use in pregnant patients. It is advisable to monitor for any adverse effects and to counsel women of childbearing potential regarding the lack of available data.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate that users may experience temporary discomfort, which can include sensations of burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it has been noted that frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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 20° to 25°C (68° to 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. For children aged 2 to under 6 years, it is recommended to administer 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, with a maximum of 2 doses in any 24-hour period. For children under 2 years of age, consultation with a doctor is advised 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 Children Afrin Extra Moisturizing Stuffy Nose Pump Mist, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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