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 fever, headache, sore throat, minor aches and pains, cough due to minor throat and bronchial irritation, nasal congestion (for daytime use only), and runny nose and sneezing (for nighttime use only).

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. The maximum allowable dosage is 8 capsules within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 capsules taken with water every 4 hours as needed.

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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

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

• Use in children for the purpose of inducing sleep is contraindicated, as it is not intended for this indication.

Additionally, it is advised to avoid exceeding the recommended dosage and to refrain from consuming alcoholic beverages while using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that contain acetaminophen concurrently, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

Healthcare professionals should recommend that patients consult a doctor before using this product if they have any of the following conditions: cough with excessive phlegm, liver disease, difficulty urinating due to prostate enlargement, heart disease (daytime use only), diabetes (daytime use only), thyroid disease (daytime use only), high blood pressure (daytime use only), or persistent or chronic cough associated with smoking, asthma, or emphysema (daytime use only). For nighttime use, patients with breathing problems or chronic cough, as well as those with glaucoma, should seek medical advice prior to use.

Patients taking the anticoagulant warfarin or those using sedatives or tranquilizers (nighttime use only) should consult a healthcare professional or pharmacist before using this product.

In the event of an accidental overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, regardless of whether symptoms are present.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness (daytime use only), if pain, nasal congestion, or cough worsens or persists beyond seven days (daytime use only), if pain or cough worsens or lasts more than seven days (nighttime use only), if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious 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 concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of 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, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness, particularly during daytime use. Patients should also monitor for worsening pain, nasal congestion, or cough lasting more than seven days, as well as fever that worsens or persists beyond three days. Redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache may indicate a serious condition, warranting immediate medical consultation.

When using this product, patients should adhere to the recommended dosage to avoid adverse effects. Notably, excitability may occur, especially in children during nighttime use, and marked drowsiness is a potential side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and caution is advised when driving or operating machinery.

Patients with specific medical conditions should consult a healthcare provider prior to use. These conditions include cough with excessive phlegm, liver disease, difficulty urinating due to prostate enlargement, heart disease, diabetes, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), and glaucoma. Furthermore, individuals taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other products containing acetaminophen or in individuals consuming three or more alcoholic beverages daily.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious side effects. It is advised to avoid the use of dextromethorphan in patients currently taking MAOIs or within two weeks of discontinuing them.

The concomitant use of warfarin with this product may elevate the risk of bleeding. It is recommended that INR levels be monitored closely in patients receiving this combination.

Caution is advised when using the Nighttime formulation in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness.

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 12 years of age should consult a healthcare professional before use. For patients aged 12 years and older, the recommended dosing is as follows: during the daytime, 2 capsules should be taken with water every 4 hours, not exceeding 8 capsules in a 24-hour period. For nighttime use, 2 capsules should be taken with water every 6 hours, also not exceeding 8 capsules in a 24-hour period.

Caution is advised as excitability may occur, particularly in children when using the nighttime formulation. It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 prostate gland enlargement. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin. Care should be taken to adhere to the recommended dosage, as exceeding this may pose risks, especially in individuals with reduced kidney function.

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 potential for liver damage.

Additionally, patients with a history of liver disease are advised to 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 signs of hepatotoxicity early.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any specific nonclinical toxicology data. Additionally, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an accidental overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to carefully read the dosing instructions for both NIGHTTIME and DAYTIME products to ensure they are taking the correct dosage. It is important to stress that they must not exceed the recommended dosage.

Providers should inform patients that excitability may occur, particularly in children when using the NIGHTTIME product. Additionally, patients should be cautioned against consuming alcoholic beverages while taking the NIGHTTIME product, as this can exacerbate marked drowsiness, which is a common side effect.

Furthermore, healthcare providers should highlight that the use of alcohol, sedatives, and tranquilizers may increase drowsiness when taking the NIGHTTIME product. Patients should be advised to exercise caution when driving a motor vehicle or operating machinery due to the potential for significant drowsiness.

Storage and Handling

The product is supplied in a tamper-evident package. Healthcare professionals should ensure that the outer package remains unopened and that the blister is intact before use. The expiration date and lot number can be found on the end flap of the packaging.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to protect the product from heat, humidity, and light to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. In the event of an accidental overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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)