Basic Care Nighttime Severe Cold and Flu

Description

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, and Doxylamine Succinate are the active ingredients in this formulation, which serves multiple therapeutic purposes, including pain relief, fever reduction, nasal decongestion, cough suppression, and antihistamine activity. This product is designed for maximum strength efficacy and is presented in a liquid dosage form. It features a honey flavor for palatability. 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, headache, fever, sore throat, 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 to prevent the risk of overdose.

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) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Patients should verify with a healthcare provider if their current medications include an MAOI.

• Administration for the purpose of inducing sleep in children is contraindicated.

• History of allergic reactions to this product or any of its components precludes its use.

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. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, a cough that produces excessive phlegm, difficulty urinating due to an enlarged prostate, or any breathing problems such as emphysema or chronic bronchitis. Additionally, individuals with a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, should also consult a healthcare provider. It is also recommended that patients inform their doctor or pharmacist if they are taking blood thinners like warfarin or any sedatives or tranquilizers.

In the case of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should discontinue use and contact their 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 advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting beyond a reasonable duration may indicate a serious condition requiring prompt evaluation.

Side Effects

Severe adverse reactions associated with the use of acetaminophen include the potential for severe liver damage, particularly if an adult exceeds 4,000 mg in a 24-hour period, a child takes more than five doses in 24 hours, 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 risk of severe skin reactions, 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.

Participants should also be advised to consult a healthcare provider if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving or operating machinery.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Before using this product, 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. Additionally, individuals experiencing persistent or chronic cough, or those with difficulty urinating due to an enlarged prostate gland, should seek medical advice prior to use.

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

Drug Interactions

The concomitant use of this product with certain medications may lead to significant interactions that require careful consideration.

Anticoagulants The use of this product alongside warfarin may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Sedatives and Tranquilizers Co-administration with sedatives or tranquilizers may enhance drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery. Monitoring for excessive sedation is recommended.

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) The use of this product is contraindicated in patients currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric conditions, or Parkinson’s disease, due to the potential for serious interactions.

Alcohol The consumption of alcohol in conjunction with this product may also increase drowsiness. Patients should be advised to limit or avoid alcohol intake while using this product to mitigate the risk of enhanced sedation.

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 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. If pain, nasal congestion, or cough worsens or persists beyond 5 days in children, or 7 days in adults, medical advice should be sought. Additionally, if fever worsens or lasts more than 3 days, further evaluation is necessary.

In the event of an overdose, immediate medical assistance should be obtained, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are 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 considered in these populations to ensure maternal and fetal safety.

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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period, as exceeding this limit may lead to significant hepatic injury.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. This consultation is essential to evaluate the appropriateness of the medication and to determine any necessary dosage adjustments or monitoring requirements based on the severity of their liver function impairment. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional before use.

Acetaminophen has been associated with severe skin reactions, 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. Additionally, excitability may occur, particularly in children, and marked drowsiness has been reported. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness. Other potential effects include feelings of nervousness, dizziness, or insomnia.

Symptoms such as worsening pain, nasal congestion, or cough that persists beyond 5 days in children or 7 days in adults should be monitored closely. A fever that worsens or lasts more than 3 days, along with the presence of redness or swelling, may indicate a serious condition. The emergence of new symptoms or a cough that recurs or is accompanied by a rash or headache that persists should also be evaluated for potential underlying issues.

No specific information regarding carcinogenicity, mutagenicity, or impairment of fertility is provided in the available data. Furthermore, there is no detailed information on animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 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 must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

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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