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, cough suppression, antihistamine action, and nasal decongestion. The product is presented in a liquid dosage form with a berry flavor and is alcohol-free. 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, 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 the 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 take the medication only as directed, adhering to the overdose warning. The provided dose cup must be used for accurate measurement. It is imperative not to exceed 4 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 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for 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, or 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 for liver damage. Healthcare professionals should advise patients that severe liver damage 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 drinks daily while using 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 a skin reaction, patients must 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 be instructed to consult a physician promptly.

General precautions should be taken when considering the use of this product. Patients should be advised to consult a healthcare provider prior to use 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, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), or if they are on a sodium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should 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 or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly 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 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 cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, medical consultation is advised promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients are advised to stop use and consult a healthcare provider if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage to avoid adverse effects. Notably, excitability may occur, particularly in children, and marked drowsiness is a possibility. 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 with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems (e.g., emphysema or chronic bronchitis) should consult a healthcare provider before use. Additionally, those experiencing persistent or chronic cough, or who are on a sodium-restricted diet, should seek medical advice prior to use.

It is also important for patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin to consult a doctor or pharmacist before using this product. Pregnant or breastfeeding individuals should seek guidance from a healthcare professional prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking any other medications that contain acetaminophen, whether prescription or nonprescription. The risk of acetaminophen-related hepatotoxicity may be increased with concomitant use.

Caution is advised for patients who are on prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric disorders, or Parkinson’s disease. The use of this product is contraindicated during MAOI therapy and for a period of two weeks following the discontinuation of an MAOI.

Additionally, patients taking the anticoagulant warfarin should seek medical advice before using this product, as there may be an increased risk of bleeding.

While using this product, it is recommended to avoid the consumption of alcoholic beverages. The combination of alcohol with this product, as well as with sedatives and tranquilizers, may enhance drowsiness and impair cognitive and motor functions. Monitoring for increased sedation is advised in patients who are using these substances concurrently.

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 prior to use. The product is contraindicated in children under 4 years of age.

Caution is advised as excitability may occur, particularly in 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 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. 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of 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 consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on therapy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the risks and benefits of therapy in these patients.

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. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, patients who consume three or more alcoholic beverages daily while using acetaminophen are at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider the need for liver function tests and other relevant evaluations. Prompt intervention is crucial to mitigate the potential for serious complications associated with acetaminophen overdosage.

Nonclinical Toxicology

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

Excitability may occur, particularly in children, and marked drowsiness has been observed.

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

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of acetaminophen, reported voluntarily or through surveillance programs.

Severe skin reactions have been noted, which may manifest as skin reddening, blisters, or 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 instances of marked drowsiness.

Healthcare professionals are encouraged to advise patients to stop use and consult a doctor if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 7 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Furthermore, an overdose warning is emphasized, advising individuals to seek medical help or contact a Poison Control Center immediately in the event of an overdose, as prompt medical attention is crucial 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, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed 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.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last 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. They should also be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should inform patients to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be advised to consult a doctor if new symptoms arise or if a cough recurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product 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 gland, or a persistent or chronic cough related to smoking, asthma, or emphysema. Those on a sodium-restricted diet should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this product if they are taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

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 a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor, while use is not recommended for children under 4 years of age.

Patients should be counseled to avoid alcoholic beverages and to exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness. They should seek medical attention if they experience worsening symptoms such as nervousness, dizziness, sleeplessness, or if pain, nasal congestion, or cough persists beyond 7 days. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, patients should consult a healthcare professional. It is crucial to adhere to the recommended dosage, using only the provided dose cup, and not to exceed 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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