Nasal Decongestant Pe

Description

Phenylephrine HCl is the active ingredient in this formulation, providing a maximum strength nasal decongestant at a dosage of 10 mg per tablet. The product is designed for the relief of congestion and sinus pressure, and is presented in a dosage form of 72 tablets. This formulation is non-drowsy, allowing for use without sedation. The packaging is tamper evident; it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. Manufactured with care for H-E-B® in San Antonio, TX 78204, this product is backed by a 100% guarantee, offering a replacement or refund if the customer is not completely satisfied.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, 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 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 a period of 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 dosage while using this product is also contraindicated.

Warnings and Precautions

It is imperative that this product 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, this product should not be taken for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current prescription medications.

Before initiating treatment, it is essential for patients to seek medical advice if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate gland enlargement. These conditions may necessitate closer monitoring or alternative therapeutic strategies.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay to ensure appropriate management.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, it is crucial to seek medical attention promptly.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.

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. Furthermore, it should not be used for 2 weeks following the cessation of an MAOI. Patients uncertain about whether their prescription includes an MAOI are advised to consult a doctor or pharmacist prior to using this product.

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, psychiatric or emotional conditions, and 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, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Nasal Decongestant Pe (phenylephrine hcl). 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 aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 includes reports of adverse reactions such as nervousness, dizziness, and sleeplessness. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should counsel patients to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within 7 days or are accompanied by fever.

Patients should be reminded to adhere to the recommended dosage and not exceed it while using this product. Additionally, healthcare providers should encourage patients to consult with their doctor before 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 tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). For reference, the expiration date and lot number can be found on the end flap of the packaging.

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

View product document (PDF)