Resfridol

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold symptoms, specifically targeting cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, which facilitates the drainage of bronchial tubes and enhances the productivity of coughs.

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

Dosage and Administration

The dosage of the medication is determined by age and should be administered using the dosage cup provided. Prior to administration, the solution must be shaken well to ensure proper mixing.

For adults and children aged 12 years and older, the recommended dosage is 20 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 10 mL every 4 hours. It is important to note that the medication should not be used in children under 6 years of age.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period to avoid potential overdose.

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 they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients are instructed to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an accidental overdose, it is imperative to obtain emergency medical assistance immediately or contact a Poison Control Center. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional prior to use.

In clinical practice, patients are instructed to discontinue use and seek medical advice if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients should consult a healthcare provider before using this product if they have a cough that is accompanied by excessive phlegm or if they experience a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a health professional before use.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Resfridol (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 10 mL every 4 hours. In contrast, adults and children 12 years and older may take 20 mL every 4 hours. Care should be taken to adhere to these age-specific dosing guidelines to ensure safety and efficacy.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

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

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

Management of an overdose typically involves supportive care and symptomatic treatment. It is recommended that healthcare providers monitor the patient closely for any signs of toxicity and initiate appropriate interventions based on the clinical presentation.

In summary, timely medical intervention and careful monitoring are critical components in the management of overdose cases to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in a configuration that includes a safety seal over the cap. It is essential to ensure that the safety seal is intact; do not use the product if the seal is torn, broken, or missing.

For optimal storage, the product should be maintained at a temperature range of 68-77°F (20-25°C). Proper handling and storage conditions are crucial to preserve the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)