Cold and Flu

Description

Acetaminophen, a pain reliever and fever reducer, is present at a dosage of 650 mg. Dextromethorphan HBr, a cough suppressant, is included at a concentration of 30 mg. Doxylamine succinate, an antihistamine, is formulated at 12.5 mg. The product also contains 10% alcohol.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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 guidelines to avoid potential overdose. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times.

For children under 12 years of age, the product is not recommended for use.

When patients are using other Day Time or Night Time products, they must carefully read each label to confirm the correct dosing to prevent exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use. It is also crucial to inquire about concurrent use of sedatives, tranquilizers, or the anticoagulant warfarin, as these may interact adversely with acetaminophen.

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

Monitoring and Follow-Up Patients should be advised to discontinue use and contact their healthcare provider if pain or cough worsens or persists beyond seven days, if new symptoms arise, if fever intensifies or lasts more than seven days, if redness or swelling occurs, or if a cough recurs with a rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume 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.

Participants should be cautious of excitability, particularly in children, and marked drowsiness may occur. It is advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery.

Patients are advised to stop use and consult a healthcare professional if pain or cough worsens or persists beyond seven days, if new symptoms arise, if fever intensifies or lasts more than seven days, if redness or swelling is observed, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms could indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek advice from a healthcare provider or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

An overdose warning is in place, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within two weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Caution is advised when using this medication in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may affect anticoagulation control.

It is important to note that the use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness. Monitoring for increased sedation is recommended in patients who are using these substances concurrently.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available information. However, it is important to note that the product is intended for use in adults and children aged 12 years and older, which suggests that its safety and efficacy in younger populations have not been established.

While there are no explicit warnings tailored to geriatric patients, general warnings may still be pertinent. Healthcare providers should advise elderly patients to consult a doctor before use if they have liver disease, as this condition may affect the metabolism of the product. Additionally, caution is warranted for those taking sedatives or tranquilizers, as the concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, a factor that could pose significant risks for elderly patients.

Given these considerations, healthcare providers should monitor elderly patients closely for any adverse effects and ensure that they are informed about the potential interactions and risks associated with the use of this product.

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 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 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 of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. In the event of an overdose, which may result from taking more than the recommended dose, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Monitoring of liver function may be warranted in patients with compromised liver function to mitigate the risk of potential liver damage.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of proactive management even in the absence of observable signs or symptoms of overdose.

Prompt recognition and treatment of an overdose can significantly impact patient outcomes, making it essential for healthcare professionals to act swiftly and decisively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, 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 if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with a doctor or pharmacist prior to using this product.

It is important to instruct patients not to combine this product with any other medications that contain acetaminophen, whether prescription or non-prescription. Patients should be encouraged to verify the contents of their medications with a healthcare professional if they are unsure.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days. They should also seek medical advice if new symptoms arise, if fever intensifies or lasts beyond seven days, or if any redness or swelling occurs. Additionally, patients should be cautioned to stop use and contact a doctor if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children, and marked drowsiness may occur. Therefore, patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. It is also recommended that patients consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, regardless of the presence of 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)