Cold and Flu

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 sore throat, nasal congestion, minor aches and pains, cough due to minor throat and bronchial irritation, and headache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is imperative that no more than 4 doses are taken within a 24-hour period.

Healthcare professionals should instruct patients to utilize only the dose cup provided to ensure accurate measurement and administration. The product is not recommended for use in children under 6 years of age. It is essential to adhere strictly to the dosing guidelines and not exceed the recommended dosage.

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, as this may lead to serious drug interactions. Patients should verify with a healthcare professional if their current medications include an MAOI.

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

Additionally, it is imperative not to exceed the recommended dosage to avoid potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4,000 mg of acetaminophen within a 24-hour period, while children should not take more than 5 doses in the same timeframe. Additionally, caution is warranted if this product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

General precautions should be taken when considering the use of this product. Patients should be encouraged to consult a healthcare provider prior to use if they have any of the following conditions: high blood pressure, difficulty urinating due to prostate enlargement, a cough associated with excessive phlegm, liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), heart disease, diabetes, or thyroid disease. Furthermore, it is essential to inquire about the concurrent use of warfarin, a blood-thinning medication, as this may necessitate additional monitoring.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to seek emergency medical help or contact a Poison Control Center right away, regardless of whether signs or symptoms are present.

Patients should also be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond 3 days; if redness or swelling occurs; if new symptoms develop; or if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults. A return of cough accompanied by rash or headache that persists should also prompt immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg in a 24-hour period, a child takes more than 5 doses in 24 hours, or if the product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Furthermore, if a patient experiences a severe sore throat that 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 using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening fever lasting more than three days, redness or swelling, the emergence of new symptoms, or if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. A cough that recurs or occurs alongside a rash or headache that lasts may indicate a serious condition and warrants immediate medical evaluation.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential bleeding complications.

Additionally, individuals using sedatives or tranquilizers should seek advice from a healthcare provider before initiating treatment. The concomitant use of these agents may enhance sedative effects, warranting dosage adjustments or increased monitoring for sedation-related adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In contrast, adults and children aged 12 years and over may take 30 mL every 4 hours during the day and 30 mL every 6 hours at night.

Caution is advised as excitability may occur, particularly in children. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older. It is essential for geriatric patients to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, high blood pressure, heart disease, diabetes, thyroid disease, difficulty in urination due to enlargement of the prostate gland, or a breathing problem or chronic cough that lasts or occurs with excessive phlegm (mucus).

Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

Elderly patients may experience marked drowsiness when using this product, and the effects may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Therefore, caution is advised when driving a motor vehicle or operating machinery.

In the event of an overdose, prompt medical attention is critical for both adults and children.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 patients with reduced kidney function, as the lack of data 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. The risk of liver injury increases significantly if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of hepatotoxicity.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should refrain from using this product, as alcohol consumption can exacerbate the potential for liver damage.

Monitoring of liver function may be warranted in patients with compromised liver function, particularly if they are using this product in conjunction with other medications or substances that may affect liver health.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific nonclinical toxicology information is available in the insert. Additionally, there is no specific animal pharmacology and toxicology information provided.

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, excitability has been reported, particularly in pediatric patients. Users may also experience marked drowsiness, which can be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Healthcare professionals should be alerted if any of the following occur: worsening pain or cough lasting more than 7 days, fever that worsens or persists beyond 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting longer. These symptoms may indicate a serious underlying condition.

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult with a doctor prior to use if they have any of the following conditions: high blood pressure, difficulty urinating due to prostate gland enlargement, a cough accompanied by excessive phlegm (mucus), liver disease, a persistent or chronic cough associated with smoking, asthma, or emphysema, heart disease, diabetes, or thyroid disease.

Additionally, healthcare providers should recommend that patients ask a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin. This precaution is essential to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 30 mL of the medication every 6 hours at night and every 4 hours during the day. Clinicians should counsel patients on the importance of consulting 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 or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children, even in the absence of noticeable symptoms.

Additionally, clinicians may refer to www.StopMedicineAbuse.org for information regarding the potential for medicine abuse among teenagers. No further information is 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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