Care One Nasal

Description

CAREone® is a nasal spray formulation containing 0.05% oxymetazoline hydrochloride, serving as a nasal decongestant. This product is designed for the relief of nasal congestion associated with colds and allergies, providing fast and powerful relief for up to 12 hours. The no-drip feature ensures that the solution does not leak from the nose or down the throat, enhancing user comfort. The dosage form is a pump mist, and the product is gluten-free. Each container holds 1 fluid ounce (30 mL).

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

Adults and children aged 6 to under 12 years, under adult supervision, may receive 2 or 3 sprays in each nostril. This administration should not occur more frequently than every 10 to 12 hours, and it is essential not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is advised prior to use.

Prior to administration, the product must be shaken well. To prepare the device, hold the white tabs, squeeze the grooved area of the cap firmly, and turn it counterclockwise. Before the initial use, the metered pump should be primed by firmly depressing the pump several times.

For the actual spraying process, 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. A firm, even stroke should be used to fully depress the rim while simultaneously sniffing deeply. After use, the nozzle must be wiped clean, and the cap should be secured to maintain hygiene and prevent contamination.

Contraindications

Use is contraindicated in the following situations:

• The product should not be used for more than 3 days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

• Do not exceed the directed dosage, as misuse may result in adverse effects.

• The use of this container by more than one person is contraindicated due to the risk of spreading infection.

Warnings and Precautions

Before using this product, it is imperative for healthcare professionals to advise patients 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. These conditions may increase the risk of adverse effects or complications associated with the use of this product.

When administering this product, it is crucial 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, 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 container with others may facilitate the spread of infection.

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 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 Care One Nasal (oxymetazoline 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 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 healthcare professional is advised prior to use.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers may use this medication to temporarily relieve nasal congestion associated with common cold, hay fever, and upper respiratory allergies. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the potential benefits and risks when recommending this treatment to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

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. The national Poison Control Center can be reached 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 recommended to ensure patient safety and effective recovery.

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 potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort may occur following the use of the product. Reported symptoms include burning, stinging, sneezing, and an increase in nasal discharge. These events have been 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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to adhere strictly to the recommended dosage and duration. Patients should not use more than directed and should not use the product for more than three days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Inform patients that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, caution should be taken as the use of this container by more than one person may increase the risk of spreading infection.

Healthcare providers should also encourage patients to consult a doctor before 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.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced as needed. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°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, standard precautions should be taken to maintain the integrity of the product during storage.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, it is recommended to use 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, with a maximum of 2 doses within a 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)