Basic Care Nighttime Severe Cold and Flu

Description

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, and Dextromethorphan HBr are the active ingredients in this formulation, which serves multiple therapeutic purposes including pain relief, fever reduction, nasal decongestion, cough suppression, and antihistamine activity. The product contains 10% alcohol and is presented in an original flavor. It is classified as a maximum strength formulation and is available in a dosage form of 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, minor aches and pains, headache, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and reduces swelling of nasal passages, thereby facilitating nasal and/or sinus drainage and restoring freer breathing through the nose.

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.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum limit of 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should emphasize the importance of not exceeding the maximum dosage to avoid potential overdose, as detailed in the accompanying warnings.

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. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should verify with a healthcare professional if their prescription includes an MAOI.

• History of allergic reaction 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 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 imperative 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. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 be instructed to consult a physician without delay.

General Precautions 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, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. 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 crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, regardless of whether they exhibit signs or symptoms of overdose.

Monitoring and Follow-Up Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with a rash or headache lasting longer than expected. 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.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. Additionally, excitability may occur, particularly in children, and marked drowsiness is a common adverse reaction. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days, fever lasting more than three days, redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting an extended period, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as emphysema or chronic bronchitis. Those with an enlarged prostate gland, persistent or chronic cough (as seen in smoking, asthma, or emphysema), or those on a sodium-restricted diet should also consult a healthcare provider. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist prior to use.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Co-administration of this medication with other products 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 any 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.

The concomitant use of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may potentiate drowsiness. Patients should be advised to exercise caution and consider avoiding these substances to mitigate the risk of excessive 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 4 to under 12 years should consult a healthcare professional before use. The medication is contraindicated in children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect that may affect children.

In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

For dosing, adults and children aged 12 years and older may take 30 mL every 4 hours. For children aged 4 to under 12 years, a healthcare provider should be consulted for appropriate dosing recommendations.

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 efficacy, 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 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 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. 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 known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to ensure safety and to mitigate the risk of hepatotoxicity.

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 intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

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

Excitability has been observed, particularly in pediatric populations, and marked drowsiness may also occur.

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 associated with acetaminophen use have been noted, with symptoms including skin reddening, blisters, and 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, alongside marked drowsiness. Users are advised to stop use and consult a healthcare professional if pain, nasal congestion, or cough worsens or persists beyond 7 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if cough recurs with rash or headache lasting longer than expected, as these may indicate a serious condition.

An overdose warning has been issued, emphasizing the importance of obtaining medical help or contacting a Poison Control Center (1-800-222-1222) immediately in the event of an overdose. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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, emphasizing the importance of prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage, as taking more than directed can lead to serious health risks. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Providers should counsel patients to avoid consuming alcoholic beverages while using this medication, as alcohol can exacerbate drowsiness. Additionally, patients should be cautioned about the potential for increased drowsiness when combined with sedatives or tranquilizers.

Finally, healthcare providers should remind patients to exercise caution when driving or operating machinery, as the medication may impair their ability to perform these tasks safely.

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 environmental factors that may compromise the product's quality.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians should counsel patients to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery due to the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients are advised to seek medical attention if they experience worsening symptoms such as pain, nasal congestion, or cough lasting more than 7 days, fever lasting more than 3 days, or the presence of redness or swelling. New symptoms, a recurrence of cough, or cough accompanied by a rash or headache that persists should also prompt a consultation, as these may indicate a serious condition. It is crucial for patients to adhere strictly to the dosing instructions, using only the provided dose cup and not exceeding 4 doses within a 24-hour period.

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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