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 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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, not to exceed 4 doses within a 24-hour period. For children aged 6 to under 12 years, the appropriate dosage is 15 mL every 4 hours, also limited to a maximum of 4 doses in a 24-hour timeframe.

It is imperative to instruct patients to utilize only the dose cup provided for accurate measurement. The product is not recommended for use in children under 6 years of age.

Patients should be cautioned against exceeding the directed dosage to avoid potential adverse effects.

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 provider 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

This product contains acetaminophen, which carries significant risks for liver damage. Severe liver injury may occur if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in the same timeframe, if it is used concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

In cases of overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. A return of cough accompanied by rash or headache that persists may indicate a serious underlying condition, necessitating further evaluation.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in 24 hours, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes 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. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; 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 should be evaluated by a healthcare professional.

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 due to potential alterations in anticoagulant effects.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Patients are advised to verify the presence of acetaminophen in any other medications they may be taking by consulting a healthcare provider or pharmacist.

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, while adults and children 12 years and older may take 30 mL every 6 hours. It is important not to exceed 4 doses within a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is also a potential side effect. The medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments or safety concerns outlined in the prescribing information; however, caution is advised when administering this product to individuals aged 65 and older. The product is indicated for adults and children aged 12 years and older, with a recommended dosage of 30 mL every 6 hours for the nighttime formulation and 30 mL every 4 hours for the daytime formulation, not exceeding a maximum of 4 doses in a 24-hour period.

It is important to consult a healthcare provider prior to use, particularly for elderly patients who may have liver disease, as this condition can lead to reduced liver function and may affect the metabolism of the product. Additionally, caution should be exercised when this product is used in conjunction with other medications, as older adults often take multiple prescriptions, increasing the risk of drug interactions.

Elderly patients may exhibit increased sensitivity to side effects, necessitating careful monitoring for any adverse effects, especially in those with underlying health conditions or those on concurrent medications. Regular assessment of the patient's response to treatment is recommended to ensure safety and efficacy.

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 specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 be advised that this product contains acetaminophen, which carries a risk of severe liver damage. The risk is particularly heightened if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, or if a child takes more than five doses in the same timeframe. Additionally, the concurrent use of other medications containing acetaminophen may further increase the risk of liver damage.

Patients with a history of liver disease or those who consume three or more alcoholic drinks daily should consult a healthcare professional prior to using this product. It is essential for patients with compromised liver function to be closely monitored for any signs of liver injury, and dosage adjustments may be necessary based on individual liver function assessments.

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 arising from an overdose. 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 data or animal pharmacology and toxicology data have been provided in the insert.

Postmarketing Experience

Postmarketing experience has identified that excitability may occur, particularly in pediatric populations. Additionally, marked drowsiness has been reported among users. It is noted that the concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects, leading to increased drowsiness.

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 crucial 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 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 also inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should be advised to stop using the product and seek medical advice if their fever worsens or persists for more than three days, if they notice any redness or swelling, or if new symptoms arise. Additionally, patients should be instructed to stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults. They should also be made aware that a returning cough or one accompanied by a rash or persistent headache may indicate a serious condition, warranting medical evaluation.

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 difficulty urinating due to prostate gland enlargement, a cough associated with excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they have any of the following conditions: heart disease, diabetes, thyroid disease, liver disease, or high blood pressure. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to use.

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 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 may refer to resources such as www.StopMedicineAbuse.org to understand the risks associated with 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.

View product document (PDF)