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 minor aches and pains, nasal congestion, headache, fever, sore throat, sinus congestion and pressure, and cough due to minor throat and bronchial irritation. It is specifically indicated for nighttime use to alleviate cough, runny nose, and sneezing.

Additionally, this drug reduces swelling of the nasal passages and temporarily restores freer breathing through the nose. It promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive during the daytime.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the specified limits. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets from both Daytime and Nighttime products within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated; if there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a current prescription, a healthcare professional should be consulted.

Finally, patients should not take DAYTIME and NIGHTTIME products simultaneously.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic drinks daily while taking this product.

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

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

Healthcare professionals should inquire about the following conditions before recommending this product: liver disease, diabetes, high blood pressure, glaucoma (for nighttime use), thyroid disease, heart disease, cough associated with excessive phlegm, persistent or chronic cough (such as that seen in smoking, asthma, chronic bronchitis, or emphysema for daytime use), difficulty urinating due to prostate enlargement, and any breathing problems or chronic cough lasting into the night.

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, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare provider 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 lasting longer than expected, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Patients should be advised to consult a healthcare professional prior to using this product if they have a history of liver disease, diabetes, high blood pressure, glaucoma (for nighttime use), thyroid disease, heart disease, or if they experience a cough associated with excessive phlegm or a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema (for daytime use). Furthermore, individuals with difficulty urinating due to prostate enlargement or chronic breathing problems should also seek medical advice before use.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness, especially when the product is used at night. Patients are cautioned against exceeding the recommended dosage and should avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving or operating machinery during nighttime use.

Patients are advised to stop using the product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness, if pain, nasal congestion, or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

This product should not be used by individuals who have previously experienced an allergic reaction to it or any of its ingredients, or in conjunction with any other drug containing acetaminophen. It is also contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication.

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, doxylamine succinate, guaifenesin, phenylephrine hcl). 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 taken with water every 4 hours.

Caution is advised as excitability may occur, particularly in children, when used at nighttime. Additionally, marked drowsiness may also be experienced during nighttime use. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this medication. While there are no specific dosage adjustments or recommendations outlined for this population, caution is advised when prescribing to geriatric patients.

It is essential to consult a healthcare provider prior to use if the elderly patient has any of the following conditions: liver disease, diabetes, high blood pressure, glaucoma (specifically for nighttime use), thyroid disease, heart disease, or difficulty in urination due to prostate gland enlargement. Monitoring for adverse effects and overall treatment response is recommended to ensure patient safety and efficacy of the therapy in this demographic.

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, particularly if they experience difficulty in urination due to enlargement of the 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a known history of liver disease should consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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 comprehensive care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

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, reports indicate that users should stop taking acetaminophen and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than 7 days, as well as fever that worsens or persists beyond 3 days. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts may also indicate a serious condition requiring medical evaluation.

Patient Counseling

Patients should be advised 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 present.

Healthcare providers should instruct patients not to take DAYTIME and NIGHTTIME products concurrently, as this may lead to adverse effects. It is important to emphasize the necessity of adhering to the recommended dosage and not exceeding it.

Patients should be made aware that excitability may occur, particularly in children, when using the NIGHTTIME product. Additionally, marked drowsiness is a potential side effect associated with the NIGHTTIME formulation.

Patients are advised to avoid consuming alcoholic beverages while using the NIGHTTIME product, as this can exacerbate drowsiness. Caution should also be exercised when driving a motor vehicle or operating machinery after taking the NIGHTTIME product due to the risk of impaired alertness. Furthermore, patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness when using the NIGHTTIME formulation.

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). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

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 taken with water every 4 hours. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding prior to using the medication. Additionally, resources are available for understanding the risks of medicine abuse among teens 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.

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