Cold and Flu

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, sore throat, cough, headache, minor aches and pains, and sinus congestion and pressure. Additionally, it temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours as needed. It is imperative that patients do not exceed 12 caplets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended. Healthcare professionals should ensure that patients understand the importance of not exceeding the directed dosage to avoid potential adverse effects.

Contraindications

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are used for certain psychiatric or emotional conditions and Parkinson’s disease, and their interaction with this product may lead to serious adverse effects. Verify with a healthcare professional if there is uncertainty regarding MAOI status.

• In individuals with a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is crucial to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as blisters, rash, or skin reddening. Should any skin reaction occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, diabetes, thyroid disease, a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), heart disease, or high blood pressure. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

Emergency Medical Help In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if they experience new symptoms, redness or swelling, nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days. A return of cough accompanied by a rash or headache that lasts may indicate a serious condition requiring further evaluation.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product.

Patients should be aware of the potential for severe skin reactions, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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

Patients are advised to stop use and contact a doctor if new symptoms arise, if redness or swelling occurs, or if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or lasts longer than seven days, or if fever worsens or persists beyond three days, medical advice should be sought. A return of cough or its occurrence alongside a rash or headache that lasts may indicate a serious condition requiring attention.

Before using this product, patients with pre-existing conditions such as liver disease, diabetes, thyroid disease, or heart disease should consult a healthcare provider. Those experiencing a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent coughs associated with smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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 caplets every 4 hours, with a maximum dosage not exceeding 12 caplets in a 24-hour period. In the event of an overdose, it is crucial to seek prompt medical attention for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 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 are advised to monitor the patient closely and provide supportive care as necessary. The management of overdose may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to gather as much information as possible regarding the substance, the amount ingested, and the time of exposure to facilitate appropriate treatment.

In summary, timely medical attention is vital in overdose situations to ensure the best possible outcomes for affected individuals.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, no findings are reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions, including blisters, rash, and skin reddening, associated with the use of acetaminophen. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical 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 about the presence of acetaminophen in their medications, 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 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 with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if new symptoms arise, or if there is any redness or swelling.

Patients should also be advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed to consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days. Patients should be made aware that a returning cough, especially if accompanied by a rash or headache that lasts, could indicate a serious condition, warranting medical attention.

When using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have liver disease, diabetes, thyroid disease, or a cough associated with excessive phlegm. Patients experiencing difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or those with heart disease or high blood pressure should also be advised to seek medical guidance prior to use.

Finally, patients taking the blood-thinning medication warfarin should be instructed to consult a doctor or pharmacist before using this 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). For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that 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 12 caplets in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

Additionally, it is important to educate patients about the potential for medicine abuse, particularly among teens. Resources such as www.StopMedicineAbuse.org can provide further information on this topic. No further details are available regarding laboratory tests or postmarketing experiences.

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.

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