Stona Cough

Description

The product is identified by the SPL code 34089-3 and is presented in a carton format. It is associated with a media type of image/jpeg, which is referenced as StonaCoughCart.jpg.

Uses and Indications

This drug is indicated for the temporary relief of cough and nasal congestion associated with the common cold. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 12 years of age and over are advised to take 2 tablets every 6 to 8 hours, with a maximum dosage not to exceed 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 6 to 8 hours, with a maximum limit of 4 tablets in a 24-hour period, or as directed by a healthcare provider.

For children under 6 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

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 two weeks following the discontinuation of an MAOI due to the potential for serious interactions.

Patients should also be advised not to exceed the recommended dosage while using this product, as this may lead to adverse effects.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this medication.

Warnings The use of this medication is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is essential to refrain from using this medication for at least two weeks following the discontinuation of an MAOI.

General Precautions Prior to use, patients should consult a healthcare professional if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, high fever, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough accompanied by excessive phlegm (mucus). Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use. It is also advisable for patients taking any prescription medications to consult with a doctor or pharmacist to confirm whether their medication contains an MAOI.

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

Discontinuation and Consultation Patients are advised to discontinue use and consult a healthcare provider if any of the following occur: symptoms persist for more than one week or if the cough tends to recur, as a persistent cough may indicate a serious underlying condition; the onset of nervousness, dizziness, or sleeplessness; the presence of a rash or persistent headache accompanying the cough; or if symptoms are accompanied by fever.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the contraindication of use 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, it is advised that patients refrain from using this product for at least two weeks after discontinuing an MAOI.

Before using this product, patients should consult a healthcare professional if they have a history of heart disease, thyroid disease, high blood pressure, high fever, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough accompanied by excessive phlegm. It is also important to seek medical advice if the patient has a persistent or chronic cough, which may be indicative of serious underlying conditions such as smoking-related issues, asthma, chronic bronchitis, or emphysema.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a doctor if symptoms persist for more than one week, if the cough tends to recur, or if they experience nervousness, dizziness, or sleeplessness. Patients should also seek medical attention if their cough is accompanied by a rash or persistent headache, or if symptoms are accompanied by fever.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease.

Patients should refrain from using this medication if they are currently taking an MAOI or have discontinued an MAOI within the past two weeks. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating this medication if they are uncertain whether their current prescription includes an MAOI. This precaution is critical to avoid potential adverse interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Stona Cough (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may take 1 tablet every 6 to 8 hours, with a maximum of 4 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 6 years of age, it is advised to consult a doctor before administration.

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 available data on the excretion of this medication 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

In summary, timely medical intervention and thorough assessment are critical components in the management of overdose cases.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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, sleeplessness, rash, persistent headache, and fever. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this medication should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. It is important to discuss the potential risks associated with combining these medications.

Healthcare providers should instruct patients to discontinue use and consult a doctor if symptoms persist for more than one week, if a cough tends to recur, or if they experience nervousness, dizziness, or sleeplessness. Patients should also be advised to seek medical attention if their cough is accompanied by a rash, persistent headache, or if symptoms are accompanied by fever, as these may indicate a more serious condition.

When using this product, patients must be cautioned not to exceed the recommended dosage.

Providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, high fever, diabetes, difficulty urinating due to an enlarged prostate gland, a cough accompanied by excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Lastly, patients should be advised to ask a doctor or pharmacist before use if they are taking any prescription drugs and are unsure whether those medications contain an MAOI.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It is essential to protect the container from light exposure to ensure optimal stability and efficacy. Proper storage conditions should be observed to prevent degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)