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, fever, headache, minor aches and pains, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours as needed. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. It is important to note that the medication should not be used in children under 6 years of age.

Patients should not exceed 5 doses within a 24-hour period. To ensure accurate dosing, it is essential to utilize only the dose cup provided with the medication. Additionally, patients are advised not to take more than the directed dosage.

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 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, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• In individuals with a known allergy to this product or any of its ingredients, due to the risk of severe allergic 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 containing acetaminophen under specific circumstances. Adults should 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. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to 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 doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: 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, thyroid disease, or high blood pressure. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider 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 a rash or headache that persists may indicate a serious condition requiring medical evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver damage and severe allergic reactions.

Severe liver damage may occur if an adult takes 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 taken concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt medical consultation.

Common adverse reactions that may necessitate discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, or sleeplessness; worsening fever lasting more than three days; presence of redness or swelling; emergence of new symptoms; and worsening pain, nasal congestion, or cough lasting more than five days in children or seven days in adults. A cough that recurs or occurs with a rash or headache that persists may indicate a serious condition and should be evaluated by a healthcare professional.

Before using this product, patients should consult a doctor if they have 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, thyroid disease, or high blood pressure.

Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as concurrent use may elevate the risk of bleeding. No additional drug interactions or laboratory test interactions have been identified for this medication. Monitoring for signs of increased bleeding is advisable in patients who are co-administered warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. The use of this medication is not recommended for children under 6 years of age.

Healthcare professionals should be aware of a liver warning indicating that if a child takes more than 5 doses within a 24-hour period, medical advice should be sought. Additionally, caregivers are advised to stop use and consult a doctor if the child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of this medication for elderly patients.

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 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 should consult a healthcare professional prior to use if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before using this medication. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than 5 doses in a 24-hour period, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

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 should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed 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 identified through surveillance programs.

Patient Counseling

Patients should be advised to seek immediate medical help 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 initially apparent.

It is important to inform patients that this product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, or if they have stopped taking an MAOI within the past two weeks. If patients are unsure whether their prescription medication contains an MAOI, they should seek guidance from a healthcare professional.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

If patients notice that their fever worsens or persists for more than three days, they should stop using the product and seek medical advice. Additionally, they should be informed to stop use and consult a doctor if they observe any redness or swelling, 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. Patients should also be advised to seek medical attention if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage. They should be encouraged to consult a doctor before use if they have difficulty urinating due to an enlarged prostate gland, a cough accompanied by excessive phlegm, liver disease, a persistent or chronic cough related to smoking, asthma, or emphysema, heart disease, diabetes, thyroid disease, high blood pressure, or if they are taking the blood-thinning medication warfarin.

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). Temporary excursions are permitted within the range of 15° to 30°C (59° to 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 regarding the importance of consulting a health professional if they are pregnant or breastfeeding before using the medication.

Additionally, it is important to raise awareness about the potential for medicine abuse among teens, with resources available at www.StopMedicineAbuse.org. 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)