Nighttime Severe Cold and Flu

Description

Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride are the active ingredients in this formulation. The product is presented in a liquid dosage form, with a total volume of 12 fluid ounces (354 mL). It is flavored with a berry essence to enhance palatability.

Uses and Indications

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

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 provided dose cup must be used for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

This medication is not indicated for use in children under 4 years of age.

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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that contain acetaminophen concurrently, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, 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 the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), or those on a sodium-restricted diet. Additionally, patients should consult a doctor or pharmacist prior to use if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who 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.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling occurs, or if new symptoms develop. A return of cough or the occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those with a history of chronic cough, emphysema, or chronic bronchitis should seek medical advice before using this product. Furthermore, individuals on a sodium-restricted diet or those experiencing trouble urinating due to an enlarged prostate gland should also consult a healthcare provider prior to use.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

While using this product, it is crucial to adhere to the recommended dosage to avoid adverse effects. Patients, particularly children, may experience excitability, and marked drowsiness may occur. Caution is advised when driving or operating machinery, as the use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised when using this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric disorders, or Parkinson’s disease. Patients should seek guidance from a healthcare provider if they are currently taking an MAOI or have discontinued such treatment within the past two weeks.

The concomitant use of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety.

Additionally, the use of alcohol, sedatives, and tranquilizers alongside this medication may potentiate drowsiness. Patients should be advised to exercise caution and consider avoiding these substances to mitigate the risk of excessive sedation.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional prior to use. The product is contraindicated in children under 4 years of age.

Caution is advised as excitability may occur, particularly in pediatric patients. 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 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 therapeutic response, 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 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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on this medication. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the risks and benefits of therapy in these patients.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in individuals who consume three or more alcoholic beverages daily while using acetaminophen. Alcohol can exacerbate the hepatotoxic effects of acetaminophen, increasing the likelihood of liver injury.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's liver function and consider the administration of N-acetylcysteine (NAC) as an antidote, particularly if the overdose is identified within a critical time frame. Continuous monitoring of liver enzymes and supportive care may also be necessary to manage the patient's condition effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use due to potential teratogenic effects.

Excitability may occur, particularly in children, alongside marked drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of acetaminophen. Reports indicate that acetaminophen may cause severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Healthcare professionals are advised to instruct patients to discontinue use and consult a doctor if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should also be advised to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. New symptoms that arise should prompt a consultation with a healthcare provider, as should a cough that returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage. 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 well as to exercise caution when driving or operating machinery. The combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough related to smoking, asthma, or emphysema. Additionally, patients on a sodium-restricted diet or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also seek advice from a healthcare professional prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Proper container requirements must be adhered to, and special handling considerations should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients on the potential effects of the medication, including increased drowsiness when combined with alcohol, sedatives, or tranquilizers. Patients should be advised to exercise caution when driving or operating machinery. They should seek medical attention if they experience worsening symptoms such as persistent pain, nasal congestion, or cough lasting more than 7 days, fever lasting more than 3 days, or the presence of redness or swelling. New symptoms, a returning cough, or a cough accompanied by a rash or headache warrant further evaluation, as these may indicate a serious condition. Patients must adhere to the dosing instructions, using only the provided dose cup and not exceeding 4 doses within a 24-hour period.

Drug Information (PDF)

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

View product document (PDF)