Multi-Symptom Cold

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed the directed amount, and patients must not take more than six doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 10 mL, administered using the dosing cup provided, every 4 hours as needed. It is essential to utilize only the dosing cup included with the product to ensure accurate measurement.

Children under 12 years of age should not use this medication.

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 contains an MAOI.

Exceeding the recommended dosage while using this product is also contraindicated.

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 using this product.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to prostate gland enlargement, or a cough that produces excessive phlegm. Special caution is warranted for patients with a persistent or chronic cough, particularly those with a history of smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to 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 fever, or if a cough persists for more than one week, recurs, or is associated with fever, rash, or persistent headache, these may indicate a serious condition requiring medical evaluation.

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. A persistent cough lasting more than one week, especially if it tends to recur or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and warrants immediate medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents and children aged 12 years and older, the recommended dosage is 10 mL, administered using the dosing cup provided, every 4 hours as needed. It is important to note that the maximum dosage should not exceed 6 doses within a 24-hour period.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 not been specifically addressed in the drug insert 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 absence of detailed guidance 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 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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These reactions may occur in patients using the product.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to emphasize the importance of adhering to the recommended dosage and not exceeding it.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed to seek medical advice if their symptoms do not improve within 7 days or if they are accompanied by a fever. It is also important to alert patients that a cough persisting for more than one week, recurring coughs, or coughs accompanied by fever, rash, or persistent headache may indicate a serious condition and warrant medical evaluation.

Before initiating treatment, healthcare providers should encourage patients to discuss their medical history, particularly if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to prostate gland enlargement, cough associated with excessive phlegm, or persistent or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. This information is vital for ensuring safe and effective use of the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 10 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use.

Additionally, resources are available for understanding the risks of medicine abuse among teens at www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)