Dextromethorphan hydrobromide/Acetaminophen/Phenylephrine hydrochloride

Description

The drug is a combination of active and inactive ingredients. The active ingredient is insert active ingredient name here, which has a chemical name of insert chemical name here, a molecular formula of insert molecular formula here, and a molecular weight of insert molecular weight here. The inactive ingredients include insert inactive ingredients here. This formulation is presented in the form of insert dosage form, e.g., tablet, solution, etc.. The physical characteristics of the drug are insert physical characteristics, e.g., color, shape, size, etc..

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, not to exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In 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 treatment. This is to prevent potential serious interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 softgels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, individuals with a persistent or chronic cough, such as those with smoking-related conditions, asthma, or emphysema, should also seek medical advice. Patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and contact a healthcare provider if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 softgels within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also stop use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or persists for more than three days; if redness or swelling is observed; if new symptoms develop; or if a cough recurs or occurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Severe liver damage may occur if the maximum daily dosage of this product, which is 8 softgels within 24 hours, is exceeded, particularly when used concurrently with other medications containing acetaminophen. It is advised that patients avoid exceeding this dosage to mitigate the risk of hepatotoxicity.

Additionally, the concurrent use of this product with three or more alcoholic beverages daily may significantly increase the risk of severe liver damage. Patients are advised to limit alcohol consumption while using this product to reduce the potential for adverse hepatic effects.

No specific drug or laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Multi Symptom. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The safety and efficacy of this medication have not been established in children under 4 years of age, and its use is not recommended in this population.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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 or nursing infant.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects associated with acetaminophen, which is a component of this formulation.

It is critical to note that severe liver damage may occur if patients exceed the maximum recommended dosage of 8 softgels within a 24-hour period. This limit applies not only to the use of this product alone but also in conjunction with other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Due to these considerations, careful monitoring of liver function and adherence to recommended dosages is essential for patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) 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 medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, 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 or emotional disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. When using this product, patients must be reminded not to exceed the recommended dosage.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Quick medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed of potential severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In such cases, discontinuation of the medication and prompt medical consultation are necessary. Additionally, if a patient experiences a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a doctor without delay.

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu Multi Symptom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)