Nighttime Cold and Flu Relief

Description

Acetaminophen, at a dosage of 650 mg, serves as a pain reliever and fever reducer. The formulation also includes Dextromethorphan HBr, which is present at 30 mg and functions as a cough suppressant. Additionally, Doxylamine succinate is included at a dosage of 12.5 mg, acting as an antihistamine. The product contains 10% alcohol as an inactive ingredient.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines to avoid potential overdose. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times to facilitate proper administration.

For children under 12 years of age, the product is not recommended for use. When patients are using other Daytime or Nighttime products, they must carefully read each label to confirm the correct dosing to prevent exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for 2 weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to stop using the product and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than seven days; new symptoms develop; fever worsens or persists beyond three days; redness or swelling is observed; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Patients may experience severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any of these symptoms occur, it is imperative to stop use and seek medical assistance promptly. Additionally, 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 doctor immediately.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. 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 healthcare professional if pain 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 present, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

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.

It is important to note that 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 using these substances concurrently.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, it is critical to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information available regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of detailed data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities that may influence treatment outcomes in this population.

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 currently no available data regarding the excretion of this medication 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 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 absence of detailed guidance 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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a total of 4,000 mg of acetaminophen within a 24-hour period, particularly if they are also taking other medications that contain acetaminophen or consuming three or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. Additionally, patients should be aware of the overdose warning associated with acetaminophen. Taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is essential, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with liver damage and to ensure appropriate care is provided.

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 these contexts.

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 be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is crucial to stress that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

When using this product, healthcare providers should inform patients that excitability may occur, particularly in children. Patients should be made aware that marked drowsiness is a possible side effect and that they should avoid consuming alcoholic beverages while using the product. Additionally, caution should be exercised when driving a motor vehicle or operating machinery, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: pain or cough worsens or persists for more than 7 days; new symptoms develop; fever worsens or lasts more than 3 days; redness or swelling is observed; or if a cough returns or occurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition that requires medical evaluation.

Storage and Handling

The product is supplied in specific packaging configurations, with relevant NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, 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 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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 Nighttime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)