Natuheal Original Nasal

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

Adults and children aged 6 years and older, under adult supervision, are advised to administer 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and the total number of doses should not exceed 2 in a 24-hour period.

The use of this medication is not recommended for children aged 2 years and under. Additionally, it is contraindicated for children under 6 years of age.

Administration should be performed via the intranasal route, ensuring that the spray is directed into each nostril as specified.

Contraindications

Use of this product is contraindicated in the following situations:

Exceeding the recommended dosage is prohibited, as it may lead to adverse effects. Additionally, the product should not be used for more than 3 days. Prolonged or frequent use may result in the recurrence or worsening of nasal congestion, as well as temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge.

Furthermore, the use of this container by more than one person is contraindicated due to the potential risk of spreading infection.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult a physician prior to use 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 and require careful consideration before initiating treatment.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional before use. The safety of the medication during these periods has not been fully established, and professional advice is crucial to ensure the well-being of both the patient and the child.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Should symptoms persist despite use, it is advised to discontinue the medication and consult a healthcare provider. Ongoing symptoms may indicate a need for reevaluation of the treatment plan or further investigation into the underlying condition.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a healthcare professional prior to use if there is a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional before using this medication to ensure safety for both the mother and child.

These precautions are essential to mitigate potential adverse reactions and ensure the safe use of the medication in individuals with pre-existing health conditions.

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 Natuheal Original Nasal (naphazoline hcl 0.05% original nasal). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 to under 6 years, the use is also not recommended. In children 6 years and older, the medication may be administered with adult supervision at a dosage of 2 or 3 sprays in each nostril, not to be used more frequently than every 10 to 12 hours, and should not exceed 2 doses within a 24-hour period.

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. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and its effects on fetal outcomes are not fully understood. Therefore, healthcare providers should exercise caution and consider alternative treatments when necessary.

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 drug 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 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 and monitoring.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of exposure, is crucial for effective treatment and follow-up care.

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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge, has been reported in postmarketing experience. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to emphasize that patients should not exceed the recommended dosage and should refrain from using the product for more than three days. Patients must be instructed to 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 increased nasal discharge, may occur.

Providers should caution patients against sharing the container with others, as this may facilitate the spread of infection. Patients should be advised to stop using the product and consult a doctor if their symptoms persist. For those who are pregnant or breastfeeding, it is essential to recommend consulting a health professional before use.

Additionally, healthcare providers should encourage patients to discuss their medical history, particularly if they have heart disease, high blood pressure, thyroid disease, diabetes, or experience difficulty urinating due to an enlarged prostate gland, as these conditions may influence the safety and efficacy of the product.

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° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to ensure the product remains within the specified temperature range throughout its storage period.

Additional Clinical Information

The medication is administered nasally, with the recommended dosage for adults and children aged 6 years and older being 2 or 3 sprays in each nostril, not to exceed 2 doses within a 24-hour period and administered no more frequently than every 10 to 12 hours. It is contraindicated for use in children under 6 years of age, as well as in those under 2 years.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the medication out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)