Vicks Formula 44dm

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with a cold.

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

Dosage and Administration

Patients should take the medication only as directed and utilize the dose cup provided for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 6 to 8 hours, with a maximum of 4 doses within a 24-hour period.

For children aged 6 to under 12 years, the dosage is 15 mL every 6 to 8 hours, also adhering to the maximum of 4 doses per 24 hours.

For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not recommended for use in children under 4 years of age.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

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 of this product 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, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

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

Before using this product, patients should consult a healthcare provider if they have a cough that produces excessive phlegm (mucus) or if they experience a persistent or chronic cough associated with smoking, asthma, or emphysema. These conditions may necessitate a different therapeutic approach or further investigation.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. It is crucial for patients to consult with a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Common adverse reactions include the need to discontinue use if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition, warranting further medical evaluation.

Patients should also seek medical advice before using this product if they experience a cough that produces excessive phlegm (mucus) or if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. This precaution is essential to avoid potentially serious interactions that may arise from the pharmacodynamic effects of both drug classes. Monitoring for adverse effects is advised if there is any uncertainty regarding the timing of MAOI cessation.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Formula 44dm (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered a dosage of 15 mL every 6 to 8 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

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 safe use during pregnancy and lactation.

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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an 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 the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient 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 regarding nonclinical toxicology or animal pharmacology and toxicology available at this time.

Postmarketing Experience

Postmarketing experience has indicated that the following adverse reactions have been reported: dizziness, nausea, vomiting, and gastrointestinal disturbances. These events were identified through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed to discontinue use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have a cough that occurs with excessive phlegm (mucus) or if they experience a persistent or chronic cough associated with conditions such as smoking, asthma, or emphysema. This precaution is essential to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in packaging that does not meet USP requirements for light-resistant packaging. It should be stored at a temperature not exceeding 25°C to maintain its integrity and efficacy. Special care should be taken to protect the product from light exposure during storage.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Vicks Formula 44dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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