Stona-S

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, influenza, or hay fever. Specifically, it alleviates minor aches and pains, headache, sore throat, nasal congestion, runny nose, sinus congestion and pressure, cough due to minor throat and bronchial irritation, as well as sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 capsules orally every 4 hours as needed for symptom relief. The total dosage must not exceed 6 doses (12 capsules) 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 should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

The product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted.

Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI to avoid potential interactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage. The maximum daily amount is 12 capsules within a 24-hour period. Patients should be cautioned against taking this product in conjunction with other medications that contain acetaminophen, as this increases the risk of liver damage. Additionally, consumption of three or more alcoholic drinks daily while using this product may exacerbate the risk of severe liver injury.

It is imperative that this product not be administered to children under 12 years of age unless specifically directed by a healthcare provider.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; a sore throat persisting beyond 2 days; symptoms of nervousness, dizziness, or sleeplessness; or any of the following potentially serious conditions: fever worsening or lasting more than 3 days; a severe sore throat; a sore throat accompanied or followed by high fever, headache, rash, nausea, or vomiting; presence of redness or swelling; emergence of new symptoms; or a cough that recurs or is associated with a rash or headache lasting longer than expected.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 12 capsules within 24 hours, use other drugs containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients may experience excitability, particularly in children, as well as marked drowsiness. The sedative effects may be enhanced when this product is used in conjunction with alcohol, sedatives, or tranquilizers.

Patients are advised to discontinue use and consult a healthcare professional if pain, cough, or nasal congestion worsens or persists for more than seven days, if a sore throat lasts more than two days, or if symptoms such as nervousness, dizziness, or sleeplessness occur. Serious conditions may be indicated by worsening fever lasting more than three days, severe sore throat, sore throat accompanied by high fever, headache, rash, nausea, or vomiting, presence of redness or swelling, occurrence of new symptoms, or a cough that returns or occurs with a rash or headache lasting.

Patients should seek medical advice before using this product if they have liver disease, heart disease, high blood pressure, diabetes, thyroid disease, glaucoma, difficulty urinating due to prostate enlargement, or a breathing problem such as emphysema or chronic bronchitis. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm, should consult a healthcare professional prior to use.

Patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should also seek guidance from a doctor or pharmacist before using this product.

This product is not recommended for children under 12 years of age unless directed by a healthcare professional. In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is essential to avoid this medication for at least two weeks following the discontinuation of an MAOI to prevent serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, individuals who are using sedatives or tranquilizers should seek advice from a healthcare provider before initiating this medication. The concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects, leading to increased drowsiness and potential impairment. Monitoring for excessive sedation is advised in these cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not receive this medication unless specifically directed by a healthcare professional. It is advised that caregivers consult a doctor before administering this treatment to children in this age group.

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 potential adverse effects or changes in efficacy, 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 regarding 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 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 should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 12 capsules within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

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 for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of this product. These include allergic reactions, such as anaphylaxis; liver injury; skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis; gastrointestinal bleeding; renal impairment; cardiovascular events, such as hypertension and arrhythmias; and central nervous system effects, including seizures and hallucinations.

Reports of these adverse reactions have been received from various sources, including spontaneous reports and clinical studies. The frequency of these adverse reactions is not known, as they are based on voluntary reports. Healthcare professionals are encouraged to report any adverse events or side effects related to the use of this product to the appropriate regulatory authorities.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is essential to instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be advised not to use this medication for two weeks after discontinuing an MAOI.

Patients should be counseled to stop using the medication and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, they should seek medical advice if a sore throat lasts more than two days.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Patients should also be made aware of the signs of serious conditions, such as a fever that worsens or lasts more than three days, a severe sore throat, or a sore throat accompanied by high fever, headache, rash, nausea, or vomiting. They should be instructed to seek medical attention if redness or swelling occurs, new symptoms develop, or if a cough returns or occurs with a rash or headache that lasts.

While using this product, patients must not exceed the recommended dosage. They should be cautioned that the medication may cause excitability, particularly in children, and they should refrain from driving or operating machinery while using it. Patients should also avoid alcoholic beverages, as the medication may cause marked drowsiness, which can be exacerbated by alcohol, sedatives, and tranquilizers.

Patients with liver disease, heart disease, high blood pressure, diabetes, thyroid disease, glaucoma, difficulty urinating due to prostate enlargement, or breathing problems such as emphysema or chronic bronchitis should be advised to consult a doctor before using this product. This also applies to patients with a persistent or chronic cough, particularly if it is accompanied by excessive phlegm.

Finally, patients should be encouraged to ask a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It is essential to protect the container from light exposure to maintain the quality of the product. The recommended storage temperature range is between 15° to 30°C (59° to 86°F). Proper handling and storage conditions are crucial for preserving the efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)