Cold Flu Severe

Description

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Guaifenesin are the active ingredients in this formulation, which serves multiple therapeutic purposes including pain relief, fever reduction, cough suppression, nasal decongestion, and expectoration. The product is presented in the form of 24 caplets, designed for oral administration. The formulation is characterized by a cool taste, enhancing patient compliance.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, nasal congestion, and cough. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. The drug also temporarily reduces fever.

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

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 to ensure proper release and absorption of the medication. It is important to note that the total dosage should not exceed 10 caplets 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 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) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. Verification of the presence of an MAOI in prescription medications should be conducted with a healthcare professional.

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

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

Warnings and Precautions

This product contains acetaminophen, and it is crucial to adhere to the maximum daily dose of 10 caplets (3,250 mg acetaminophen) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any skin reaction occur, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider 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 persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking the anticoagulant warfarin.

It is essential that patients do not exceed the recommended dosage while using this product.

In the event of an overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or 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 fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who 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.

Patients may experience severe skin reactions, including skin reddening, blisters, and rash, which necessitate immediate cessation of use and prompt medical attention. Additionally, 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 doctor without delay.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have taken one within the past two weeks should also avoid this product. Individuals with a history of allergic reactions to this product or any of its ingredients should refrain from use.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those with coughs producing excessive phlegm, should consult a healthcare professional prior to use. Patients taking the blood-thinning medication warfarin should also seek guidance from a doctor or pharmacist.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Flu Severe (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). 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. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The formulation contains acetaminophen, which has specific dosing considerations for individuals with compromised liver function.

The maximum recommended daily dose of this product is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. It is critical to note that severe liver damage may occur if the total daily intake of acetaminophen exceeds 4,000 mg. Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an increased risk of severe liver damage when using this product. Therefore, careful monitoring and adherence to the recommended dosage are essential for patients with hepatic impairment to mitigate the risk of adverse effects.

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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified 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 through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed 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 inform patients that this product should not be used 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 if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. They should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to discontinue use and consult a doctor 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 or a recurrence of cough, especially if accompanied by a rash or persistent headache, should also prompt patients to seek medical attention, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. It is essential for patients to consult a doctor before use 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. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use. Those experiencing a cough with excessive phlegm should also consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product in a dry place at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper storage conditions are critical for maintaining the integrity of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Patients should swallow the caplets whole and not crush, chew, or dissolve them. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)