Severe Cold and Flu

Description

NDC 63868-003-24, QUALITY CHOICE Severe Cold & Flu is formulated for adults and contains a combination of active ingredients including Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, and Guaifenesin. This product serves multiple therapeutic purposes: it acts as a pain reliever and fever reducer, nasal decongestant, cough suppressant, and expectorant. It is indicated for the relief of headache, fever, sore throat, nasal congestion, cough, and chest congestion, effectively clearing out mucus. The dosage form consists of 24 caplets with a cool taste.

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. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. Additionally, this drug 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 and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the maximum 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

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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare professional if their prescription includes an MAOI.

• History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

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 this product concurrently with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Healthcare professionals should advise patients to seek medical attention 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 must be observed when using this product. It should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use. Patients should consult a doctor before using this product 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 persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, those taking the anticoagulant warfarin should seek advice from a healthcare professional prior to use. It is imperative that patients do not exceed the recommended dosage while using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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 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 should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should seek guidance from a healthcare professional. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have taken one within the past two weeks should avoid this product. Those with a known allergy to this product or any of its ingredients should also refrain from use.

Patients are advised to consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. It is also recommended that individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a healthcare professional before using this product.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition.

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

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

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 potential hypertensive crises or other serious adverse effects.

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 necessary to ensure safe and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Flu (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 essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating 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 acetaminophen intake exceeds 4,000 mg in a 24-hour period. Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can significantly increase the risk of severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an elevated risk for severe liver damage when using this product. Therefore, careful monitoring and adherence to dosing guidelines are essential for patients with hepatic impairment to mitigate potential risks associated with acetaminophen use.

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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as skin rash, itching, and hives. Instances of liver injury have been noted, including cases of acute liver failure. Gastrointestinal bleeding and renal impairment have also been reported.

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented. Additionally, cardiovascular events such as hypertension and palpitations have been observed. Neurological events, including seizures and dizziness, have also been reported in the postmarketing setting.

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 medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication 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 includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product 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 that arise should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Patients should 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. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. Furthermore, patients experiencing a cough accompanied by excessive phlegm should consult a healthcare provider prior to use.

Lastly, 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 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 crucial for maintaining the integrity of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older should take 2 caplets every 4 hours, ensuring they are swallowed whole without crushing, chewing, or dissolving. The maximum dosage should not exceed 10 caplets within a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are 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, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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