Severe Cold and Flu

Description

Acetaminophen, at a dosage of 650 mg, serves as a pain reliever and fever reducer. The formulation also includes dextromethorphan HBr at 20 mg, which acts as a cough suppressant. Doxylamine succinate is present at 12.5 mg, functioning as an antihistamine, while phenylephrine HCl is included at 10 mg as a nasal decongestant. This product is alcohol-free and is flavored with berry.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. These symptoms include 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, alleviates swelling of the 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. For children under 12 years of age, the use of this medication is not advised.

When utilizing either the Day Time or Night Time formulations, healthcare professionals should instruct patients to carefully read each label to ensure accurate dosing. The dosing cup should be kept with the product to facilitate proper measurement.

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 medication, 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, this product should not be used in excess of the recommended dosage, and consumption of alcoholic beverages should be avoided.

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 crucial to monitor total acetaminophen intake and advise patients to adhere strictly to dosing recommendations.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be instructed 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 is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General Precautions Patients should be cautioned against exceeding the recommended dosage, as this poses a risk of overdose. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution should be exercised when driving or operating machinery.

Emergency Medical Help In the event of an overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent.

When to Seek Medical Attention Patients should be instructed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, the emergence of new symptoms, fever persisting beyond three days, or the presence of redness or swelling should prompt immediate medical evaluation. A return of cough, particularly if accompanied by a rash or headache that persists, may indicate serious underlying conditions requiring further investigation.

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 associated with acetaminophen, 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 severe sore throat symptoms that persist for more than two days or are accompanied by fever, headache, rash, nausea, or vomiting, and should consult a healthcare provider promptly under these circumstances.

While using this product, excitability may occur, particularly in children, and marked drowsiness is a common adverse reaction. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if new symptoms arise; if fever worsens or persists for more than three days; if redness or swelling is observed; or if cough recurs or occurs with a rash or headache that lasts.

It is critical to note that taking more than the recommended dose may lead to overdose and subsequent 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 essential even if no signs or symptoms are present.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication if they are currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI treatment.

Caution is advised when this medication is used alongside 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.

It is important to note that the use of alcohol, sedatives, and tranquilizers in conjunction 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 present unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients when prescribing this medication.

Particular attention should be given to patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or urinary difficulties due to an enlarged prostate gland. These conditions may be more prevalent in the elderly population and could influence the safety and efficacy of the treatment. Therefore, it is advisable for healthcare providers to consult with a physician before initiating therapy in elderly patients who have any of these underlying health issues. Regular monitoring and assessment of the patient's response to treatment are recommended to ensure optimal outcomes.

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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 advised that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, particularly when taking other medications that also contain acetaminophen or consuming three or more alcoholic drinks daily while using this product.

Before initiating treatment, patients with liver disease should consult a healthcare professional. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at increased 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 crucial, 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 early intervention can significantly impact the outcome in cases of suspected overdose.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 importance of adhering to the recommended dosage, emphasizing that taking more than the directed amount may lead to serious liver damage. In the event of an overdose, patients should be instructed to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no symptoms are apparent.

Patients should be cautioned against using the medication in excess of the prescribed amount, reiterating the overdose warning. It is also important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect of the medication.

Providers should recommend that patients avoid consuming alcoholic beverages while taking this medication, as alcohol can exacerbate drowsiness. Additionally, patients should be made aware of the risks associated with driving or operating machinery, as the medication may impair their ability to do so safely. It is essential to inform patients that the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may further increase drowsiness, and they should exercise caution in these situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 product 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 children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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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