Equaline Nasal

Description

EQUALINE® is a fast-acting nasal spray formulated with phenylephrine hydrochloride at a concentration of 1%. This active ingredient serves as a nasal decongestant, providing relief from nasal congestion. The product is presented in a dosage form of 1 fluid ounce (30 mL). EQUALINE® is comparable to 4 Way® Fast Acting Nasal Spray in its active ingredient composition.

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 provides fast-acting relief from nasal congestion, sinus congestion, sinus pressure, and swollen nasal membranes.

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.

To ensure 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 maintain hygiene and prevent contamination.

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 advise patients to consult a physician prior to using this product 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.

When utilizing this product, it is imperative 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. Users should be informed that temporary side effects such as burning, stinging, sneezing, or an increase in nasal discharge may occur. Additionally, sharing this product among multiple users may pose a risk of infection transmission.

Patients are instructed to discontinue use and consult a healthcare provider 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 Equaline 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 adverse effects or changes in therapeutic response, 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

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.

Postmarketing Experience

Postmarketing experience has revealed reports of adverse reactions, including but not limited to nasal discomfort characterized by burning, stinging, sneezing, or an increase in nasal discharge. Additionally, there have been cases of nasal congestion worsening or returning following frequent or prolonged use. These events were reported voluntarily or identified through 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 to the following guidelines: do not exceed the recommended dosage, do not use the product for more than three days, and use it only as directed. Patients should be made aware that frequent or prolonged use may lead to a rebound effect, causing nasal congestion to return or worsen. They should also be informed that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, caution should be exercised as using this container by more than one person may facilitate the spread of infection.

Healthcare providers should encourage patients to consult a doctor before using this product 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° 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 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, consultation with a healthcare provider is recommended before use.

Clinicians should counsel patients on important safety information, including the necessity of consulting a health professional if pregnant or breastfeeding. It is also crucial to inform patients that sharing the container may lead to the spread of infection. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

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

View product document (PDF)