Careone Fast Acting Nasal

Description

CAREone® is a fast-acting nasal spray containing 1% phenylephrine hydrochloride as the active ingredient, comparable to the formulation found in 4-Way® Fast Acting Nasal Spray. This nasal decongestant is designed to relieve nasal congestion, swollen nasal membranes, sinus congestion, and sinus pressure. The product is gluten-free and is available in a 1 fluid ounce (30 mL) dosage form.

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.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 2 or 3 sprays in each nostril, not to exceed every 4 hours. For children under 12 years of age, it is recommended to consult a physician prior to use.

For proper administration, the patient should maintain a normal, upright head position. The atomizer tip should be inserted into the nostril, and the bottle should be squeezed with firm, quick pressure while inhaling. It is important to wipe the nozzle clean after each use to ensure hygiene and proper function.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or use it for more than three consecutive days. Prolonged or frequent use may lead to rebound nasal congestion, exacerbating the initial condition.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to consult a physician prior to use if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the product.

When administering this product, it is crucial to adhere strictly to the recommended dosage. Patients should not exceed the directed use and should refrain from using the product for more than three consecutive days. Prolonged or frequent use may lead to a rebound effect, causing nasal congestion to return or worsen. Temporary side effects such as burning, stinging, sneezing, or an increase in nasal discharge may occur during use. Additionally, it is important to note that sharing this container with others may pose a risk of infection transmission.

Patients should be instructed to discontinue use and seek medical advice if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 between the drug and 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 Careone Fast Acting Nasal (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 4 hours.

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

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 the safety of both the mother and the developing fetus.

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 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 without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

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 advised 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 regarding carcinogenicity, mutagenicity, or impairment of fertility has been provided in the insert. Additionally, there is no relevant data available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to instruct patients to adhere strictly to the recommended dosage and duration of use. They should not exceed the directed amount or use the product for more than three days, as frequent or prolonged use may lead to a rebound effect, causing nasal congestion to return or worsen. Patients should be made aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, it is important to inform patients that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should also encourage patients to consult a doctor prior to use if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°-25°C (68°-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 2 or 3 sprays in each nostril, not exceeding every 4 hours. For children under 12 years, it is recommended to consult a doctor regarding appropriate use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to note that sharing the container with others may lead to the spread of infection. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)