Stona Cough

Description

The product is identified by the SPL code 34089-3. It is packaged in a carton that includes panels 1 and 2. The visual representation of the product is indicated by the image file named stonacoughsyrcartA.jpg.

Uses and Indications

This drug is indicated for the temporary relief of cough 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 associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are advised to take 10 mL orally every 6 to 8 hours, with a maximum dosage not to exceed 30 mL within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing such medication. Due to the potential for serious interactions, consultation with a healthcare professional is advised if there is uncertainty regarding the presence of an MAOI in any prescription medication.

This product should not be used for persistent or chronic coughs associated with smoking, asthma, or emphysema, as these conditions may require alternative therapeutic approaches.

Additionally, use is contraindicated if the cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare provider, as this may indicate a more serious underlying condition that necessitates medical evaluation.

Warnings and Precautions

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should refrain from using this product for at least two weeks following the discontinuation of an MAOI. If there is any uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is strongly advised.

This product is not intended for the treatment of a persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema. Additionally, it should not be used if the cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare provider.

A persistent cough may indicate a serious underlying condition. Healthcare professionals should advise patients to seek medical attention if a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache.

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

Patients are also advised to discontinue use and consult a healthcare provider if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, the product should not be used for a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema. Patients should also refrain from using this product if their cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare professional.

A persistent cough may indicate a serious underlying condition. Therefore, if a cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients are advised to consult a doctor promptly.

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

Drug Interactions

The concomitant use of this product with 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 not use this product while taking an MAOI 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, if they are currently prescribed an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of the medication in this age group have not been established, and specific dosing recommendations are not provided. Caution is advised when considering treatment for children in this age range.

Geriatric Use

Elderly patients may not have specific geriatric use information, dosage adjustments, or safety concerns outlined in the prescribing information. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations associated with pharmacotherapy in the elderly 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 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 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 this medication. 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 accidental 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 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 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 several adverse reactions associated with the use of the product. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additional reported events include hallucinations, confusion, agitation, increased heart rate, respiratory depression, seizures, hepatotoxicity, and serotonin syndrome. It is important to note that other adverse reactions not listed may also occur.

Reports of these adverse reactions are based on voluntary submissions, and the frequency of these events cannot be determined from the available data. Healthcare professionals are encouraged to report any adverse events or side effects to the FDA.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

For adults and children aged 12 years and over, the recommended dosage is 10 mL every 6 to 8 hours, with a maximum of 30 mL in a 24-hour period, unless otherwise directed by a physician. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)