Basic Care Nighttime Cold and Flu

Description

This formulation provides multi-symptom relief for nighttime cold and flu symptoms. It contains active ingredients including acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. The product is alcohol-free and is packaged in a container containing 48 softgels. It is comparable to the active ingredients found in Vicks® NyQuil® Cold & Flu.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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 allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every six hours as needed.

For children aged 4 to under 12 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.

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, as well as for 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 significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, a persistent cough due to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur 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 potential for severe skin reactions associated with acetaminophen, 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.

In clinical observations, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop using this product and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

During the use of this product, excitability may occur, particularly in children, and marked drowsiness may be experienced. Patients are cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery. The concomitant 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 considering the use of 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.

Additionally, the concomitant use of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended in patients receiving both therapies to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care Nighttime Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate). 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 not recommended for children under 4 years of age.

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 potential 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. 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 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 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 individuals 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, particularly due to the presence of acetaminophen. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 toxicity.

Additionally, the risk of severe liver damage increases for individuals who consume three or more alcoholic beverages daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate liver toxicity, necessitating careful monitoring and patient education regarding alcohol consumption during treatment.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are essential components of management. In cases of significant overdose, the use of N-acetylcysteine as an antidote should be initiated as soon as possible to mitigate liver damage.

Prompt recognition and intervention are critical in managing acetaminophen overdosage effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

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

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

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. 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.

Further observations indicate that if pain or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days, medical attention should be sought. The presence of redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that persists 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 instructed 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 consult a doctor or pharmacist for clarification.

It is important 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 one within the past two weeks. Patients should be encouraged to verify with their healthcare provider or pharmacist 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 advised against its use. Additionally, they should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. They should also be cautioned to seek medical advice if a cough recurs or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be encouraged to discuss their use of these substances with their healthcare provider.

Patients with liver disease, glaucoma, or a cough associated with excessive phlegm (mucus) should be advised to consult a doctor before using this product. Additionally, those with breathing problems such as emphysema or chronic bronchitis, persistent or chronic coughs related to smoking, asthma, or emphysema, or difficulties urinating due to an enlarged prostate gland should also seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

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 any degradation of the product.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Patients are also advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)