Basic Care Nighttime Severe Cold and Flu

Description

This formulation is designed for nighttime relief of severe cold and flu symptoms. It contains a combination of active ingredients: Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, and Dextromethorphan HBr, which function as a pain reliever and fever reducer, nasal decongestant, antihistamine, and cough suppressant, respectively. The product is presented in a dosage form of 24 caplets, featuring a Max Strength formulation enhanced with Vapor Ice™ for additional relief.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, cough to facilitate sleep, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing. Additionally, this drug 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 take the medication only as directed, adhering to the overdose warning. The maximum dosage should not exceed 8 caplets within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours as needed.

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

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

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury 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 beverages daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

Emergency medical help should be sought in the event of an overdose. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; any signs of 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised 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 consult a healthcare professional promptly.

Patients are also advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough that produces excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should seek advice from a doctor or pharmacist prior to use if they are taking sedatives or tranquilizers, or if they are using the blood-thinning medication warfarin.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric, or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of the MAOI. This interaction may lead to serious adverse effects.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent, as it may increase the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care 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 4 to under 12 years should consult a healthcare professional before use. The medication is not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that may affect 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 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, particularly considering the general physiological changes that occur with aging.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the total daily dose of acetaminophen exceeds 4,000 mg. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Due to these risks, patients with compromised liver function should be advised to limit their intake of acetaminophen and to avoid concurrent use of other acetaminophen-containing products. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with acetaminophen.

Dosage Thresholds for Risk Acetaminophen is associated with a risk of severe liver damage when the total daily intake exceeds 4,000 mg within a 24-hour period. Healthcare professionals should be vigilant in assessing the total dosage of acetaminophen, particularly in patients who may be using multiple products containing this active ingredient.

Drug Interactions The risk of severe liver damage is further heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen. It is essential for healthcare providers to review all medications a patient is taking to prevent unintentional overdose.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk for severe liver damage. Healthcare professionals should inquire about alcohol use in patients prescribed acetaminophen and provide appropriate counseling regarding the risks associated with concurrent use.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Severe skin reactions associated with acetaminophen use have been noted, with symptoms including skin reddening, blisters, and rash. Additionally, instances of excitability, particularly in pediatric populations, have been documented. Marked drowsiness has also been reported, with the potential for increased sedation when acetaminophen is used concurrently with alcohol, sedatives, or tranquilizers.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain, nasal congestion, or cough lasting more than 7 days; fever worsening or persisting beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

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 proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

Patients should be informed about the oral route of administration for the medication, with specific dosing guidelines: adults and children aged 12 years and older may take 2 caplets with water every 4 hours, while children aged 4 to under 12 years should consult a doctor, and the medication is not recommended for children under 4 years.

Clinicians should counsel patients on potential side effects, including excitability, marked drowsiness, and the need to avoid alcoholic beverages. Patients should exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. They should be advised to seek medical attention if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 7 days, if fever worsens or lasts more than 3 days, or if new symptoms arise. Patients should also be aware of the importance of adhering to the recommended dosage, not exceeding 8 caplets in a 24-hour period, and to be vigilant for signs of serious conditions, such as a returning cough accompanied by a rash or headache.

Drug Information (PDF)

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

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