Resfriol D

Description

RESFRIOL D is a combination medication indicated for the relief of common symptoms associated with cold and allergy. Each tablet contains 500 mg of Acetaminophen, a pain reliever and fever reducer; 4 mg of Chlorpheniramine Maleate, an antihistamine; and 10 mg of Phenylephrine HCl, a nasal decongestant. The product is available in a dosage form of tablets, packaged in 72 pouches, each containing 2 tablets, for a total of 144 tablets. The National Drug Code (NDC) for this product is 69729-323-38. The formulation is designed to alleviate symptoms such as headache, sneezing, nasal congestion, itchy and watery eyes, and runny nose.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever or other respiratory allergies. These symptoms include headache, sinus congestion and pressure, nasal congestion, runny nose, sneezing, and minor aches and pains. Additionally, it provides temporary relief from nose or throat itching and itchy, watery eyes.

This drug also aids in clearing nasal passages and decongesting sinus openings and passages.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet taken with water every 4 to 6 hours as needed. It is imperative that patients do not exceed 6 tablets within a 24-hour period. Tablets must be swallowed whole; they should not be crushed, chewed, or dissolved to maintain the integrity of the formulation.

For children aged 4 to 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should remind patients of the importance of not exceeding the directed dosage and to be aware of the overdose warning associated with this medication.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

• History of allergic reactions to this product or any of its components, as this may result in severe allergic responses.

• Use in children for the purpose of inducing sleep, as this is not an approved indication and may pose safety risks.

Additionally, it is advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General Precautions Patients should be instructed to consult a physician prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, trouble urinating due to an enlarged prostate gland, or a respiratory condition such as emphysema or chronic bronchitis. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking blood thinners such as warfarin or sedatives/tranquilizers.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking this product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; or if new symptoms arise. These may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 6 tablets within 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be cautious regarding the use of this product if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

While using this product, excitability may occur, particularly in children, and drowsiness is a possible side effect. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain or nasal congestion worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. The presence of redness or swelling, or the emergence of new symptoms, may indicate a serious condition requiring medical evaluation.

An overdose warning is also pertinent; taking more than the directed dosage can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson’s disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Resfriol D (acetaminophen, chlorpheniramine maleate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to 12 years should consult a healthcare professional before use. The safety and efficacy of this medication have not been established in children under 4 years of age, and its use is not recommended in this population.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned in the text. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Regular monitoring may be warranted 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. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

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 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 should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dosage of this medication can lead to serious health complications. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay.

Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. They should emphasize the importance of adhering to the recommended dosage, as taking more than directed can lead to serious health issues. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is essential to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, healthcare providers should stress that this medication should not be used to induce sleepiness in children.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to seek medical advice if pain or nasal congestion worsens or persists beyond seven days, if fever intensifies or lasts more than three days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that drowsiness is a possible side effect. Patients should be cautioned that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and they should avoid alcoholic beverages while taking this medication. Furthermore, patients should exercise caution when driving or operating machinery.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, difficulty urinating due to an enlarged prostate gland, or breathing problems such as emphysema or chronic bronchitis. Additionally, patients should be advised to speak with a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that ensures integrity and safety. It should be stored at room temperature, specifically between 20-25°C (68-77°F). Temporary excursions are permissible within the range of 15°C to 30°C (59°F to 86°F).

It is essential to protect the product from excessive heat and humidity to maintain its efficacy. Additionally, the packaging is designed to be tamper evident; therefore, the product should not be used if the package or blister unit is open or exhibits any signs of tampering.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. Patients should be informed of the overdose warning, emphasizing that taking more than the directed dose can lead to serious health issues. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial, regardless of whether symptoms are present, for both adults and children.

Drug Information (PDF)

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

View product document (PDF)