Stona

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, with the reference image labeled as StonaTabCart_v3.jpg.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, influenza, or hay fever. These symptoms include 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 advised to take 2 tablets orally every 4 hours as needed for symptom relief. The total dosage should not exceed 6 doses (12 tablets) 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:

Children under 12 years of age should not be given this product unless directed by a physician.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

This product should not be used in patients 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 is contraindicated for 2 weeks following the discontinuation of an MAOI.

Exceeding the recommended dosage is contraindicated. Patients are also advised against driving or operating machinery while using this product. Consumption of alcoholic beverages should be avoided.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 12 tablets within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

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

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider 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; the presence of redness or swelling; the emergence of new symptoms; or a cough that recurs or is associated with a rash or headache lasting for an extended period.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 12 tablets within 24 hours, use it concurrently with other drugs containing acetaminophen, 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 7 days, if a sore throat lasts more than 2 days, or if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should seek medical advice if they notice any of the following signs, which may indicate a serious condition: worsening fever lasting more than 3 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 that lasts.

Before using this product, patients should consult a healthcare provider 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. Patients with a persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm, should also seek medical advice prior to use.

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

It is crucial for patients to adhere to the recommended dosage and to avoid driving or operating machinery while using this product. Alcoholic beverages should be avoided. This product should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 associated hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications 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 potentially serious interactions.

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

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects of this medication, leading to increased drowsiness. Monitoring for excessive sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Stona (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 be administered this medication unless specifically directed by a healthcare professional. For children in this age group, it is essential to consult a doctor for appropriate guidance and dosage recommendations.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions 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 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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 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 tablets within a 24-hour period. Additionally, patients should avoid concomitant use with 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 liver conditions 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 medical intervention is crucial for both adults and children, even in the absence of observable 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 comprehensive care as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

The substance may induce excitability, particularly in children. Additionally, it may lead to significant drowsiness, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, marked drowsiness, and excitability, particularly noted in children.

In cases of overdose, it is critical for both adults and children to seek prompt medical attention, even in the absence of noticeable signs or symptoms.

Patient Counseling

Patients should be advised to keep this medication out of reach of children. In the event of an overdose, it is crucial 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 present.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be advised to refrain from using this medication for at least 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.

Patients should be made aware that they need to stop using the medication and contact a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be informed of the signs that may indicate a serious condition, such as a fever that worsens or lasts more than three days, a severe sore throat, or if a sore throat is accompanied by high fever, headache, rash, nausea, or vomiting. Other concerning symptoms include redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or headache that lasts.

While using this product, patients should be cautioned not to exceed the recommended dosage. They should also be informed that the medication may cause excitability, particularly in children, and that they should avoid driving or operating machinery while using it. Furthermore, patients should refrain from consuming 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 associated with smoking, asthma, or excessive phlegm. Lastly, patients should be encouraged to ask a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin or any 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)