Severe Cold and Flu

Description

This product is a maximum strength formulation designed to relieve symptoms associated with severe nighttime cold and flu. It contains the following active ingredients: Acetaminophen, dextromethorphan HBr, doxylamine succinate, and phenylephrine HCl. The formulation effectively alleviates aches, fever, sore throat, cough, runny nose, sneezing, and nasal and sinus congestion. It is alcohol-free and features a berry flavor. The product is packaged in fluid ounces (FL OZ) and milliliters (mL).

This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® NyQuil® Severe Cold & Flu. It is tamper evident; do not use if the printed safety seal is broken or missing. The product is manufactured by PL Developments, located at 11865 S. Alameda St, Lynwood, CA 90262.

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, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, sore throat, and runny nose. Additionally, it reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and assists in cough relief to facilitate sleep.

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

Dosage and Administration

Healthcare professionals should advise patients to take the medication only as directed, with particular attention to the overdose warning. The dosing should be measured using the enclosed dosing cup specifically designed for this product; no other dosing device should be utilized.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. It is important to note that patients must not exceed 4 doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended. When administering either the Day Time or Night Time formulations, it is essential to carefully read each label to ensure accurate dosing.

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 uncertain whether a prescription drug contains an MAOI, 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 uncertainty regarding the presence of acetaminophen in 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.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to adhere strictly to the following precautions:

Liver Warning Patients must not exceed 4,000 mg of acetaminophen within a 24-hour period, as this is the maximum daily dosage. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen. Consumption of three or more alcoholic beverages daily while using this product may also increase the risk of liver damage.

Allergy Alert Acetaminophen has the potential to induce severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients are 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 it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Overdose Information In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is crucial, even if the patient does not exhibit any signs or symptoms of overdose.

Discontinuation of Use Patients should be advised to stop using this product and consult a healthcare professional if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; fever that worsens or persists for more than three days; any redness or swelling; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. 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 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 using this product may experience excitability, particularly in children, as well as marked drowsiness. Caution is advised when driving or operating machinery, and the consumption of alcoholic drinks, sedatives, or tranquilizers should be avoided, as these may exacerbate drowsiness.

Patients are advised to stop use and consult a healthcare professional 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 consultation is recommended. 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.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In cases of overdose, patients should seek medical help or contact a Poison Control Center immediately, as timely medical intervention is crucial, even in the absence of noticeable signs or symptoms.

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 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 affect anticoagulation control.

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 concurrently using these substances.

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 adolescents aged 12 years and older, the recommended dosage is 30 mL every 4 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect that may affect pediatric patients.

Geriatric Use

Elderly patients may not have specific information available regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Adjustments to dosage may be necessary based on individual patient assessments and clinical judgment.

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 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 studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for increased risk of liver damage associated with this product, which contains acetaminophen. It is critical that patients do not exceed the maximum daily dosage of 4,000 mg, as taking more than this amount can lead to severe liver damage. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen and should limit alcohol consumption to fewer than three drinks per day while using this product.

Before initiating treatment, patients with known liver disease should consult a healthcare professional. In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical attention is essential, even if the patient does not exhibit any signs or symptoms of liver damage. Prompt intervention is crucial to mitigate potential harm.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical intervention is essential, even in the absence of noticeable signs or symptoms of overdose. The potential for liver damage underscores the importance of vigilance and proactive management 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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 immediately at 1-800-222-1222, 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 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 containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to ask a healthcare professional 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 beyond seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Patients should also be cautioned to stop use and consult a doctor if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should adhere strictly to the directed dosage to avoid overdose. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients exercise caution when driving or operating machinery while using this product. Patients with specific health conditions should be encouraged to consult a doctor before use, including those with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients on a sodium-restricted diet or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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 15-30ºC (59-86ºF). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

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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