Acetaminophen/Dextromethorphan hydrobromide

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 cold and flu, including cough, sore throat, headache, minor aches and pains, and the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 softgels with water every 4 hours as needed. The maximum dosage should not exceed 8 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients currently taking 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, consultation with a healthcare professional is advised.

• Individuals who are currently on a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such treatment within the past two weeks. This includes certain medications for depression, psychiatric conditions, or Parkinson's disease. Verification of MAOI status with a healthcare provider is recommended if there is any doubt.

• Patients with a known history of allergic reactions to this product or any of its components.

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

Additionally, it is important to adhere to the recommended dosage to avoid potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 10 softgels within a 24-hour period (the maximum daily dosage), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the product should be discontinued immediately, and medical assistance should be sought without delay.

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, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

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

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 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.

Participants are advised to consult a healthcare professional 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. Additionally, patients should stop use and seek medical advice if pain or cough worsens or lasts longer than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt consultation with a healthcare provider.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema) should seek medical advice. Furthermore, individuals taking the blood-thinning medication warfarin are advised to 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 Daytime Cold and Flu. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this age group, and therefore, it is contraindicated for children in this category. Healthcare professionals are advised to consider alternative treatments for pediatric patients under 12 years.

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 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 considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 10 softgels 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, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product to mitigate 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 at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, vigilance and timely action are essential in managing potential overdose situations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a blister pack configuration. It should be stored at room temperature, specifically within the range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat. Additionally, the product must not be used if the blister unit is found to be torn or open, as this may compromise the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels orally with water every 4 hours, with a maximum of 8 softgels in a 24-hour period unless otherwise directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)