Nasal Decongestant

Description

This product is a nasal decongestant designed to relieve nasal congestion. It acts by constricting blood vessels in the nasal passages, leading to reduced swelling and improved airflow. The formulation is intended for intranasal administration, providing targeted relief for conditions associated with nasal congestion.

Uses and Indications

This drug is indicated for the temporary relief of sinus congestion and pressure. It is also indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 tablet every 4 hours as needed. The maximum recommended dosage is 6 tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dose while using this product is also contraindicated.

Warnings and Precautions

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

General precautions must be observed, particularly regarding the concurrent use of monoamine oxidase inhibitors (MAOIs). This product should not be administered to patients who are currently taking a prescription MAOI or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is any uncertainty regarding the presence of an MAOI in a patient's prescription regimen, it is imperative to consult a physician or pharmacist prior to the use of this product.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms: nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical advice should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Notably, there are no specific side effects listed in the available data. However, patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, medical advice should be sought.

Before initiating treatment, patients should inform their healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. There are no additional adverse reactions or important notes provided in the current labeling.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Nasal Decongestant (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 prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients receiving treatment. It is essential that patients with reduced creatinine clearance are closely monitored throughout their therapy. Additionally, renal function tests should be performed prior to and during treatment in patients with kidney problems to ensure safety and efficacy. A reduced dose is recommended for patients with moderate to severe renal impairment to mitigate the risk of adverse effects.

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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage cases. It is critical to document the incident thoroughly and report any adverse effects to the appropriate regulatory authorities as per local regulations.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended, prioritizing patient safety and symptom management.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. In the event of experiencing nervousness, dizziness, or sleeplessness, it is recommended to discontinue use and seek medical advice. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical consultation should be sought.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no data provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, reports have noted symptoms that do not improve within 7 days or occur in conjunction with a fever.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Patients should also be informed that if their symptoms do not improve within seven days or if they occur alongside a fever, they should seek medical advice.

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it while using this product. Furthermore, patients should be advised to consult a doctor before use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulties 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 to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours, with a maximum of six tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing guidance.

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 Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)