Daytime Severe Cold and Flu

Description

Genexa® Maximum Strength Severe Cold & Flu is a formulation designed to provide relief from symptoms associated with severe cold and flu. This product contains Acetaminophen, a recognized pain reliever and fever reducer, and Dextromethorphan HBr, a cough suppressant. It effectively addresses symptoms such as fever, headache, body aches and pains, sore throat, and cough.

The product is presented in a liquid dosage form, with a volume of 6 fl oz (177 mL). It features an organic blueberry flavor and is characterized by its commitment to clean medicine, containing the same effective active ingredients without artificial fillers.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of common cold and flu symptoms, including minor aches and pains, headache, and cough due to minor throat and bronchial irritation. Additionally, it is effective in controlling the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before each use. The medication should be taken only as directed, utilizing the dose cup provided to ensure accurate measurement. It is imperative that patients do not exceed 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 20 mL every 4 hours. 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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to using this product.

• It is also advised to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against using this product in conjunction with other medications containing acetaminophen, as well as against the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

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 advised to consult a physician without delay.

General precautions should be taken for patients with specific health conditions. It is recommended that individuals with liver disease, those experiencing a cough accompanied by excessive phlegm, or those with persistent or chronic coughs—such as those associated with smoking, asthma, or emphysema—consult a healthcare provider prior to use. 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 be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening pain or cough lasting more than seven days; fever worsening or lasting more than three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting beyond a reasonable duration. 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 if patients exceed the maximum daily dosage of four doses within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, 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, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients are also instructed to stop use and contact a doctor 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 returns or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

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

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease should avoid using this product. This contraindication extends for a period of two weeks following the discontinuation of the MAOI to prevent serious interactions.

Additionally, individuals on the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this product. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Severe Cold and Flu (acetaminophen, dextromethorphan hbr). 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 medication is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 20 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

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 therapeutic response, 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 in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients consuming three or more alcoholic drinks daily refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that early intervention can significantly impact the outcome of an overdose situation. Monitoring and supportive care may be necessary, depending on the specific circumstances and the substance involved. It is essential to provide comprehensive information regarding the overdose to medical personnel, including the amount ingested and the time of exposure, to facilitate appropriate management and treatment.

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 use of the compound in question.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated phone number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. 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 crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days. Additionally, they should stop using the product and consult a doctor if their fever worsens or lasts longer than 3 days, if they notice any redness or swelling, or if new symptoms arise. Patients should also be made aware that if their cough returns or occurs alongside a rash or headache that lasts, they should seek medical attention, as these could indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. It is important for patients to consult a doctor before using this medication if they have liver disease, a cough accompanied by excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before 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 a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)