Acetaminophen/Dextromethorphan hydrobromide/Phenylephrine hydrochloride/Doxyl...

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 and influenza, including minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, runny nose, and sneezing. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 capsules with water every 4 hours as needed. The total dosage should not exceed 4 capsules within a 12-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere to the recommended dosing guidelines and avoid exceeding 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. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

• Use in children under 12 years of age is contraindicated due to safety concerns.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk due to concurrent medication use or alcohol consumption.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms can include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. Should any signs of a skin or general allergic reaction manifest, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General Precautions This product should be kept 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 in the absence of noticeable symptoms.

Monitoring and Follow-Up Healthcare professionals should advise patients to stop taking the product and consult a doctor if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should be encouraged to seek medical advice.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of a skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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, as they should consult a doctor promptly.

It is recommended that patients stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms occur; or if a cough returns or occurs with a rash or headache that lasts. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare provider.

Before using this product, patients should seek medical advice if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as emphysema or chronic bronchitis. Those with difficulty urinating due to prostate gland enlargement or persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a doctor.

Furthermore, patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is contraindicated for this age group due to safety concerns. For adolescents aged 12 years and older, the recommended dosage is 2 capsules taken with water every 4 hours, with a maximum of 4 capsules in a 12-hour period, unless otherwise directed by a healthcare professional. This medication should not be used to sedate children.

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, particularly those aged 65 and older.

It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, as age-related physiological changes may influence drug metabolism and efficacy. Individualized assessment and clinical judgment are recommended to ensure optimal treatment outcomes in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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 the recommended dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the potential for adverse effects in this population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, which may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Healthcare professionals should be vigilant in assessing patients who may have exceeded this dosage threshold.

If an overdose is suspected or if the patient exhibits severe symptoms, immediate emergency medical assistance should be sought. Symptoms indicative of an overdose may include severe skin reactions or signs of liver dysfunction. In such instances, it is imperative for the patient to discontinue use of the medication and contact their healthcare provider without delay.

Management of acetaminophen overdosage typically involves supportive care and may require specific interventions based on the severity of the symptoms presented. Continuous monitoring of liver function and other relevant parameters is essential in guiding treatment decisions.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, respiratory symptoms such as asthma (wheezing) and shock have also been noted. In the event of a skin or general allergic reaction, it is advised to discontinue use and seek medical assistance immediately.

Other reported reactions include nervousness, dizziness, and sleeplessness. Furthermore, quick medical attention is critical for both adults and children in cases of overdose, even if no signs or symptoms are immediately apparent.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients 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.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that the medication may cause marked drowsiness, and they should be cautioned against consuming alcoholic beverages while taking it. Additionally, patients should be made aware that the combination of alcohol, sedatives, and tranquilizers can further increase drowsiness.

Healthcare providers should emphasize the need for caution when driving a motor vehicle or operating machinery due to the sedative effects of the medication. Lastly, patients should be informed that excitability may occur, particularly in children, and they should monitor for any unusual behavior.

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 a temperature range of 15ºC to 25ºC (59ºF to 77ºF) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)