Acetaminophen/Dextromethorphan hydrobromide/Doxylamine succinate

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 capsules orally with water every 4 hours. The total daily dosage must not exceed 10 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

Use is not recommended for children under 12 years of age. It is essential to adhere to the recommended dosage and not exceed the specified limits.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• History of allergic reaction to this product or any of its ingredients, which may result in severe hypersensitivity reactions.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Patients should be instructed to stop use and seek medical advice if any of the following occur: pain, cough, or nasal congestion worsens or lasts longer than seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should consult a healthcare professional.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are at increased risk if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Allergic reactions may also occur, with symptoms that can include severe skin reactions such as reddening, blisters, rash, hives, and facial swelling. Respiratory symptoms like asthma (wheezing) and more severe reactions such as shock have been reported. In the event of any skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant for signs of serious conditions, particularly if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. In such cases, prompt consultation with a healthcare provider is recommended.

Common adverse reactions may include worsening pain, cough, or nasal congestion lasting more than seven days, as well as fever that worsens or persists beyond three days. Patients should also seek medical advice if they notice redness or swelling, experience new symptoms, or if a cough recurs alongside a rash or headache that lasts.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing a persistent cough with excessive phlegm should consult a healthcare provider before using this product. Additionally, individuals with difficulty urinating due to prostate enlargement or those with chronic coughs related to smoking, asthma, or emphysema should also seek medical advice prior to use.

Finally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate. 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 2 capsules taken with water every 4 hours, with a maximum of 10 capsules in a 24-hour period, unless otherwise directed by a healthcare professional. Caution is advised to ensure adherence to the specified dosage limits.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Due to these risks, patients with compromised liver function are advised to adhere strictly to the recommended dosage and to consult healthcare professionals for personalized guidance regarding the safe use of this product. Regular assessment of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of acetaminophen. Specifically, the risk of significant hepatic injury increases when the total daily dosage exceeds 4,000 mg within a 24-hour period.

Healthcare professionals should be vigilant in identifying symptoms indicative of acetaminophen overdosage. Patients presenting with signs of overdose should be advised to seek emergency medical assistance immediately. This is particularly important if they exhibit severe symptoms, which may include but are not limited to nausea, vomiting, loss of appetite, confusion, or jaundice.

Management of acetaminophen overdosage typically involves prompt medical evaluation and intervention. Healthcare providers should consider administering activated charcoal if the patient presents within a suitable timeframe post-ingestion, and they should monitor liver function tests closely. In cases of confirmed overdose, the use of N-acetylcysteine (NAC) as an antidote should be initiated as per established protocols to mitigate liver damage and improve patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable among these are severe skin reactions, which include skin reddening, blisters, rash, hives, and facial swelling. Additionally, reports have indicated occurrences of severe allergic reactions, such as asthma (wheezing) and shock. These events were reported voluntarily or through surveillance programs and are documented for ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or within two weeks of discontinuing an MAOI. Patients should be advised to verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this product is not recommended for children under 12 years of age.

Healthcare providers should instruct patients to discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or persists beyond seven days. Similarly, patients should be advised to seek medical advice if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should also be informed to stop use and consult a doctor if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should be advised to stop use and seek medical guidance.

Patients must be reminded not to exceed the recommended dosage while using this product. It is also essential to encourage patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough related to smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40ºC (104ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)