Severe Congestion and Cough Relief

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may aid in promoting sleep. It also alleviates nasal congestion associated with colds.

Limitations of use include the absence of data regarding teratogenic or nonteratogenic effects.

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 20 mL, administered using the dosing cup provided, every 4 hours as needed. It is imperative that the dosing cup included with the product is utilized to ensure accurate measurement.

Children under 12 years of age should not be given 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 medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General precautions should be taken prior to use. Patients should be advised to seek medical consultation if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing a cough that produces excessive phlegm (mucus) should also consult a healthcare provider before use.

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

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, further medical evaluation is warranted. A cough that persists beyond seven days, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and requires prompt medical attention.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, patients should seek medical advice. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical attention.

Before using this product, patients with pre-existing conditions should consult a healthcare provider. This includes individuals with heart disease, diabetes, high blood pressure, thyroid disease, or those experiencing difficulty in urination due to prostate gland enlargement. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those with a cough that produces excessive phlegm (mucus), should also seek medical advice 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, psychiatric disorders, emotional 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 Severe Congestion and Cough Relief (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 aged 12 years and older, the recommended dosage is 20 mL, administered using the dosing cup provided, every 4 hours.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 available data on 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 absence of guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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

Teratogenic effects have been observed, and it is advised to consult a health professional prior to use. No non-teratogenic effects have been reported. Additionally, there is no available data regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 important to emphasize that patients should not exceed the recommended dosage of the medication.

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 occur alongside a fever. It is crucial to highlight that a cough persisting for more than 7 days, recurring, or accompanied by fever, rash, or a persistent headache may indicate a serious condition that requires 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, diabetes, high blood pressure, thyroid disease, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to consult a doctor if they have a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied with an expiration date indicated on the package. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Clinicians should be aware of the potential for medicine abuse among adolescents and can refer to resources such as www.StopMedicineAbuse.orgwww.StopMedicineAbuse.org for further information.

Patients who are pregnant or breastfeeding are advised to consult a healthcare professional prior to use. In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. No additional information is available regarding postmarketing experience, laboratory tests, or the route, method, and frequency of administration.

Drug Information (PDF)

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

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