Severe Cold and Flu

Description

This formulation contains Acetaminophen 650 mg, a pain reliever and fever reducer; Dextromethorphan HBr 20 mg, a cough suppressant; Doxylamine Succinate 12.5 mg, an antihistamine; and Phenylephrine HCl 10 mg, a nasal decongestant. The product is presented in a berry flavor and is alcohol-free. It is indicated for use in individuals aged 12 years and older and is classified as a maximum strength formulation.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sore throat, headache, sinus congestion and pressure, minor aches and pains, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

Additionally, this drug temporarily reduces fever and cough to facilitate sleep, decreases swelling of nasal passages, restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is 4 doses within a 24-hour period. It is imperative to measure the dosage exclusively with the dosing cup provided; the use of any other dosing device is not recommended.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. This dosage should not be exceeded. Children under 12 years of age should not use this medication.

When utilizing either the Day Time or Night Time formulations, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing. The dosing cup should be kept with the product for convenience and to promote proper administration.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is 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.

Additionally, the product should not be used in excess of the directed dosage, and consumption of alcoholic beverages should be avoided during use.

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 also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, 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.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, difficulty urinating due to an enlarged prostate, a cough associated with excessive phlegm, or any chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Additionally, patients on a sodium-restricted diet should seek medical advice before use.

Patients should also be advised to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin, as these medications may interact adversely with acetaminophen.

In the event of an 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 without delay, even if no symptoms are apparent.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms such as pain, nasal congestion, or cough worsen or persist beyond seven days, or if new symptoms arise, medical consultation is warranted. Patients should also seek medical advice if fever worsens or lasts more than three days, if redness or swelling occurs, or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate serious underlying conditions that require 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 also be cautious of the possibility of excitability, particularly in children, as well as marked drowsiness. It is advised to avoid alcoholic beverages, as they may exacerbate drowsiness, especially when combined with sedatives or tranquilizers. Patients are warned to exercise caution when driving or operating machinery due to these effects.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than three days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition requiring prompt medical evaluation.

In cases of overdose, which may result from exceeding the recommended dosage, patients are at risk for liver damage. Immediate medical attention is crucial, and individuals should contact a Poison Control Center (1-800-222-1222) without delay, 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 treatment.

Caution is advised when this medication is used 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 occur.

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 Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 4 hours. Caution is advised as excitability may occur, particularly in children.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider general precautions when prescribing to this population.

Before initiating treatment, it is advisable to inquire about any pre-existing conditions in elderly patients, including liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, urinary difficulties due to an enlarged prostate gland, or respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema. These conditions may influence the overall safety and efficacy of the treatment.

Elderly patients may experience marked drowsiness as a side effect, necessitating caution when engaging in activities that require alertness, such as driving or operating machinery. This population may exhibit increased sensitivity to drowsiness, warranting careful monitoring.

Additionally, the concomitant use of alcohol, sedatives, and tranquilizers should be approached with caution, as these substances can exacerbate drowsiness. Given that elderly patients often take multiple medications, the potential for increased sedation should be carefully evaluated to ensure patient safety.

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 no specific data available regarding the excretion of this medication in 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 patients 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at risk for liver damage. Immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) should be made without delay, as prompt medical attention is essential, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose.

Healthcare professionals should be aware that the absence of immediate symptoms does not preclude the potential for serious complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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 even if no signs or symptoms are present.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult their doctor or pharmacist before using this product.

It is important to instruct patients not to combine this product with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to ask their healthcare provider if they are unsure about the presence of acetaminophen in their other medications.

Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling occurs. Patients should also be informed to stop use and consult a doctor if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients should be cautioned against exceeding the directed dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. Patients should avoid alcoholic beverages while using this product and exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with specific health conditions should be advised to consult their doctor before using this product. These conditions include liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or any breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Patients on a sodium-restricted diet or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also seek guidance from their healthcare provider or pharmacist prior to use.

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 permitted, as it may compromise the integrity of the product. Proper handling and adherence to these storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 4 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. Additionally, it is important 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 essential, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Severe Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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