Cold and Flu

Description

This formulation contains Acetaminophen 325 mg, a pain reliever and fever reducer; Dextromethorphan HBr 10 mg, a cough suppressant; and Phenylephrine HCl 5 mg, a nasal decongestant. The product is designed as a non-drowsy, alcohol-free, and antihistamine-free option for symptomatic relief. It is presented in the form of softgels, which are liquid-filled capsules.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

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, refrain from using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms arise, patients must 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 instructed to consult a healthcare provider without delay.

It is imperative that patients do not exceed the recommended dosage of this product to mitigate the risk of adverse effects.

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, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should also be instructed to discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever that worsens or persists for more than three 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

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

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially present.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance promptly.

In addition, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional without delay.

Patients are encouraged to stop using the product and consult a doctor if they experience worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever that worsens or lasts more than three days; redness or swelling; new symptoms; or if a cough returns or occurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Overall, careful monitoring for these adverse reactions is essential to ensure patient safety while using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. This combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hydrobromide, 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. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with this product, which contains acetaminophen. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this limit can lead to serious liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which can occur if the recommended dosage is exceeded, immediate medical attention is essential. Patients should seek help or contact a Poison Control Center without delay, as prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Overdosage

Taking more than the recommended dose of this medication can lead to serious liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick medical attention is crucial, particularly for adults, and it is equally important for children, even in the absence of noticeable signs or symptoms of overdose.

Prompt intervention can significantly mitigate the risks associated with overdose and improve patient outcomes. Therefore, it is essential for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to be prepared to act swiftly in the event of an overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to serious liver damage. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, 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 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) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

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

Patients should be made aware that if their cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. It is also essential to encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or those with a cough accompanied by excessive phlegm, should also seek medical advice prior to use. Lastly, 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 available upon request. It is essential to store the product within a temperature range of 15°C to 30°C (59°F to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)