Equaline 12 Hour Decongestant

Description

Pseudoephedrine hydrochloride extended release tablets contain 120 mg of the active ingredient, serving as a nasal decongestant. These tablets are designed for a 12-hour duration of action and are formulated to be non-drowsy. The dosage form is capsule-shaped, and the product is supplied in a package containing 20 coated caplets.

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 older are instructed to take 1 tablet every 12 hours. The maximum allowable dosage is 2 tablets within a 24-hour period.

This product is contraindicated for use in children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may pose risks to patient safety.

Warnings and Precautions

Patients should not use this product if they are 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 two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance 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. These conditions may increase the risk of adverse effects and warrant careful consideration before initiating treatment.

In the event of an overdose, it is crucial to obtain emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should discontinue use and consult a healthcare provider if they experience 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 product. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur. 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, as these conditions may influence the safety and efficacy of the product.

Warnings are in place regarding the concurrent use of this product with prescription monoamine oxidase inhibitors (MAOIs). Patients must not use this product if they are currently taking an MAOI or have stopped taking one within the past two weeks. If there is uncertainty regarding the presence of an MAOI in their prescription medication, patients should consult a doctor or pharmacist prior to use.

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, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Equaline 12 Hour Decongestant (pseudoephedrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. Safety and efficacy have not been established in this age group, and the potential risks may outweigh any benefits. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this product. However, it is important to note that this population may exhibit increased sensitivity to side effects.

Caution is advised when administering this product to geriatric patients, especially those with underlying health conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland. Close monitoring of these patients is recommended to ensure safety and efficacy.

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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to be informed that they should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be instructed to stop using the product and seek medical advice if their symptoms do not improve within 7 days or if they experience symptoms accompanied by a fever.

Patients must be reminded not to exceed the recommended dosage while using this product. Furthermore, healthcare providers should encourage patients to consult with a doctor 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. This information is crucial for ensuring safe and effective use of the product.

Storage and Handling

The product is supplied in a blister pack configuration. It should be stored at a temperature range of 20-25°C (68-77°F) in a dry place, ensuring protection from light. Healthcare professionals are advised to inspect the blister unit prior to use; the product should not be used if the blister unit is broken or torn. For tracking purposes, the lot number and expiration date can be found on the end panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours. Patients should not exceed a total of two tablets within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Equaline 12 Hour Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)