Cold and Flu Nighttime Severe, 24-7 Life

Description

Cold & Flu Nighttime Severe is a combination medication formulated to relieve multiple symptoms associated with cold and flu. Each caplet contains the following active ingredients: Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; Doxylamine Succinate, an antihistamine; and Phenylephrine HCl, a nasal decongestant. This formulation is designed to alleviate headache, fever, sore throat, minor aches and pains, nasal congestion, sinus pressure, sneezing, runny nose, and cough.

The product is presented in a dosage form of 16 caplets. It is comparable to Vicks® NyQuil® VapoCOOL™ SEVERE Cold & Flu + Congestion.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and provides relief from runny nose and sneezing. The formulation also reduces swelling of nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

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:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Contraindications Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be directed to consult a doctor or pharmacist. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients with a known allergy to this product or any of its ingredients should also refrain from use.

Precautions Before using this product, patients should be advised to consult a healthcare professional if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, glaucoma, high blood pressure, difficulty urinating due to prostate enlargement, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Furthermore, patients should seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Emergency Situations In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Monitoring and Follow-Up Patients should be advised to discontinue use and contact 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 fever worsens or lasts more than three days, medical consultation is warranted. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition requiring further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are advised that liver damage may occur if they 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.

Allergic reactions may manifest as severe skin reactions, which can include symptoms such as blisters, rash, and skin reddening. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Common adverse reactions reported include excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, necessitating caution when driving or operating machinery.

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 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts may indicate a serious condition, warranting immediate medical attention.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects and increase the risk of drowsiness.

Additionally, caution is advised for patients taking warfarin or other anticoagulants. It is recommended that these patients seek guidance from a healthcare provider before initiating this medication, as interactions may affect anticoagulation control.

Alcohol, sedatives, and tranquilizers may further increase drowsiness when used in conjunction with this medication, necessitating careful monitoring of patients for excessive sedation and impairment.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Nighttime Severe, 24-7 Life (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 adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours.

Caution is advised as excitability may occur, particularly in children. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. 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 efficacy, 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 daily while using this product is not recommended, as it may exacerbate the potential for liver damage.

Additionally, patients with a known history of liver disease should consult a healthcare professional prior to using this product to ensure safety and appropriateness of treatment. 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as blisters, rash, and skin reddening. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

It is essential to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. They should also be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should counsel patients to discontinue use and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if redness or swelling occurs. Patients should also be advised to seek medical attention if new symptoms arise or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must not exceed the recommended 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 be cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be advised to exercise caution when driving a motor vehicle or operating machinery while using this product. It is important for patients to consult a doctor before use if they have liver disease, diabetes, thyroid disease, heart disease, glaucoma, high blood pressure, or difficulty urinating due to prostate gland enlargement. Additionally, patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice before use. Patients experiencing a cough with excessive phlegm (mucus) should also consult a healthcare provider.

Finally, patients should be encouraged to speak with their doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, 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 Nighttime Severe, 24-7 Life, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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