Nighttime Severe Cold and Flu

Description

This formulation contains acetaminophen, a pain reliever and fever reducer; phenylephrine hydrochloride, a nasal decongestant; dextromethorphan hydrobromide, a cough suppressant; and doxylamine succinate, an antihistamine. It is presented in a maximum strength dosage form with a honey flavor. The total volume of the product is 12 fluid ounces (355 mL).

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, and cough that may interfere with sleep. Additionally, it provides relief from minor aches and pains, headaches, sore throat, fever, runny nose, and sneezing. The formulation also reduces swelling of the nasal passages, temporarily 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 adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines and provide education on the importance of not exceeding the recommended dosage to avoid potential overdose.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek advice from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components.

• For the purpose of inducing sleep in children, as this use is not recommended.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period, while children should not take more than 5 doses in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. 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 prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate, or respiratory issues such as emphysema or chronic bronchitis. Patients with persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, should also seek medical advice before use.

Furthermore, patients should be cautioned to consult a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers, as these may interact with the product.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients are 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 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than 5 doses in the same timeframe, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use, 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.

A sore throat warning is also in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical consultation is recommended. Signs such as redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache warrant immediate medical attention, as these may indicate a serious condition.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. Caution is advised when driving or operating machinery, and the consumption of alcoholic drinks should be avoided, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, or breathing problems (e.g., emphysema or chronic bronchitis) should consult a healthcare provider before use. Additionally, those experiencing a persistent or chronic cough, particularly associated with smoking, asthma, or emphysema, should seek medical advice prior to using the product.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should also consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

The concomitant use of this product with certain medications may lead to significant interactions, categorized as follows:

Anticoagulants

• Warfarin: The use of this product alongside warfarin, a blood-thinning agent, may result in altered anticoagulant effects. Monitoring of INR levels is recommended to ensure therapeutic efficacy and safety.

CNS Depressants

• Sedatives and Tranquilizers: Co-administration with sedatives or tranquilizers may enhance drowsiness and sedation. Caution is advised, and dosage adjustments may be necessary based on the patient's response.

Acetaminophen

• This product should not be used concurrently with any other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Monoamine Oxidase Inhibitors (MAOIs)

• Patients currently taking a prescription MAOI or those who have discontinued MAOIs within the past two weeks should consult a healthcare professional prior to using this product. This is crucial to prevent potential hypertensive crises or other adverse effects.

Alcohol

• Adults consuming three or more alcoholic beverages daily while using this product may experience interactions that could exacerbate side effects. It is advisable to limit alcohol intake during treatment.

No specific laboratory test interactions have been identified in the provided information.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children under 4 years, the use of this medication is not recommended. In children aged 4 to under 6 years, consultation with a healthcare provider is advised prior to use.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, it is crucial to seek immediate medical attention for children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 healthcare professional prior to using this medication. There is currently no available data regarding 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. 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 product. The presence of liver disease may necessitate special considerations regarding the use of acetaminophen, as severe liver damage can occur under certain conditions.

It is important to note that adults should not exceed 4,000 mg of acetaminophen within a 24-hour period, as this dosage poses a significant risk for liver damage, particularly in individuals with compromised liver function. Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage.

Monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and efficacy while using this product.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to assess the patient's condition thoroughly, as timely treatment can significantly influence outcomes.

In summary, any suspected overdose situation warrants urgent action, emphasizing the importance of contacting medical professionals without delay.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in nonclinical toxicology studies. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of acetaminophen, reported voluntarily or through surveillance programs.

Severe skin reactions have been noted, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been reported, particularly in pediatric populations. Marked drowsiness is another noted effect.

Concerns have been raised regarding the persistence of certain symptoms: if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever persists or worsens beyond 3 days, medical evaluation is recommended.

The presence of redness or swelling, the emergence of new symptoms, or the recurrence of cough accompanied by rash or headache that persists may indicate a serious condition requiring further investigation.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures or humidity.

Additional Clinical Information

No further data are available.

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)