Cold and Flu Severe

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, sore throat, headache, nasal congestion, minor aches and pains, sinus congestion and pressure, sneezing, and runny nose (for nighttime use only). It aids in clearing nasal passages and provides cough relief to facilitate sleep. Additionally, this drug helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive during the daytime. It also temporarily reduces 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 caplets every 4 hours as needed. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved. It is imperative that no more than 10 caplets are taken within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

The concurrent use of DAYTIME and NIGHTTIME products is contraindicated. This combination may lead to adverse effects due to overlapping ingredients.

The use of this product is contraindicated in patients currently taking any drug 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.

Patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such treatment within the past two weeks should not use this product. MAOIs are commonly 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, a healthcare professional should be consulted prior to use.

This product is contraindicated in individuals with a history of allergic reactions to it or any of its ingredients.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic response. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant in assessing patients with severe sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be advised to consult a healthcare professional if they have liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma (particularly at night), a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking warfarin, sedatives, or tranquilizers, especially at night.

In cases of overdose, immediate medical attention is critical. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay, regardless of the presence of symptoms.

Patients should also be advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a 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 taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions, 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 immediately.

In clinical settings, patients experiencing a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting should consult a healthcare provider promptly. Additionally, patients should stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness, if pain, nasal congestion, or cough worsens or lasts more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling is present. A return of cough or occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience excitability, particularly in children, as well as marked drowsiness, especially when taken at night. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages and exercise caution when driving or operating machinery.

Patients with liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma (when taken at night), or those experiencing cough with excessive phlegm or difficulty urinating due to prostate enlargement should consult a healthcare provider before use. Additionally, patients with persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to using this product.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers (when taken at night) should also consult a doctor or pharmacist before use. In the event of an overdose, it is critical 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 initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Cold and Flu Severe (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. Caution is advised as excitability may occur, particularly in children, during nighttime administration. Additionally, marked drowsiness may be experienced in this population when used at night. It is essential for both adults and children to seek prompt medical attention, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma (for nighttime use only), or difficulty urinating due to prostate gland enlargement. Additionally, those with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use, especially if they experience breathing problems (nighttime use only).

When administering this product to geriatric patients, it is crucial to adhere to the recommended dosage, as exceeding this may lead to adverse effects. Notably, marked drowsiness may occur, and excitability is particularly noted in children (nighttime use only). Elderly patients should be advised that the consumption of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and therefore, it is recommended to avoid alcoholic beverages during use (nighttime use only). Caution is advised when driving or operating machinery, as drowsiness may impair these activities (nighttime use only).

Elderly patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 7 days, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than 3 days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache should also prompt immediate consultation, as these may indicate a serious condition.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use with other medications that contain acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 early recognition and management of overdose can significantly impact patient outcomes. Therefore, it is essential to maintain a high index of suspicion and act swiftly to ensure appropriate care is provided.

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, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days, the emergence of new symptoms, fever that worsens or persists beyond three days, redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious condition.

In cases of overdose, it is imperative to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

It is important to inform patients that they should not take DAYTIME and NIGHTTIME products simultaneously and must adhere strictly to the recommended dosage to avoid potential complications.

Healthcare providers should discuss the possibility of excitability, particularly in children, and marked drowsiness that may occur with the NIGHTTIME product. Patients should be cautioned that the use of alcohol, sedatives, and tranquilizers can enhance drowsiness when using the NIGHTTIME formulation. Therefore, patients are advised to avoid alcoholic beverages while taking this product.

Patients should exercise caution when driving or operating machinery after taking the NIGHTTIME product due to the potential for drowsiness.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor if they have any of the following conditions: liver disease, thyroid disease, diabetes, high blood pressure, heart disease, or glaucoma (specifically for the NIGHTTIME product). Additionally, patients should be advised to seek medical advice if they have a cough accompanied by excessive phlegm, difficulty urinating due to prostate enlargement, a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or any breathing problems such as emphysema or chronic bronchitis (again, specifically for the NIGHTTIME product).

Lastly, patients should be instructed to consult with a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers, particularly in relation to the NIGHTTIME product.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients on important safety measures, including the necessity of consulting a health professional if pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is vital for both adults and children, regardless of the presence of symptoms.

Additionally, clinicians should be aware of the potential for medicine abuse among teens and can refer to resources such as www.StopMedicineAbuse.org for further information. No further details are available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

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