Basic Care Daytime Cold and Flu Nighttime Cold and Flu

Description

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Doxylamine Succinate are the active ingredients in this formulation. Acetaminophen serves as a pain reliever and fever reducer, while Dextromethorphan HBr functions as a cough suppressant. Phenylephrine HCl acts as a nasal decongestant, and Doxylamine Succinate is included as an antihistamine. This product is alcohol-free and does not contain any antihistamines beyond Doxylamine Succinate. The combination of these ingredients provides a multi-symptom relief profile suitable for addressing pain, cough, nasal congestion, and allergy symptoms.

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, minor aches and pains, sore throat, headache, runny nose, sneezing, and fever.

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:

• 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 utilized 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 components, as this may lead to severe adverse reactions.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, refrain from using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant in assessing patients for severe 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, prompt consultation with a physician is warranted.

General precautions should be taken when considering this product for patients with specific health conditions. Patients should be advised to consult a healthcare professional prior to use if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing difficulties such as emphysema or chronic bronchitis, a persistent cough related to smoking, asthma, or emphysema, urinary difficulties due to an enlarged prostate, diabetes, heart disease, high blood pressure, or thyroid disease.

In cases of overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should also be advised to discontinue use and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling develops; new symptoms arise; or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition. For those using Daytime Cold & Flu, additional caution is advised if they experience nervousness, dizziness, or sleeplessness, or if pain, nasal congestion, or cough worsens or lasts beyond the specified durations.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using the product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance immediately.

In clinical trials and postmarketing experiences, participants have reported various adverse reactions. Notably, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are also instructed to stop use and consult a doctor if pain 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 with a rash or headache that lasts, as these may indicate a serious condition.

During the use of the Nighttime Cold & Flu formulation, excitability may occur, particularly in children, and marked drowsiness is common. Patients are cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Care should be taken when driving or operating machinery.

Patients with certain pre-existing conditions should consult a doctor before using the Nighttime Cold & Flu product. These conditions include liver disease, glaucoma, excessive phlegm production with cough, breathing problems such as emphysema or chronic bronchitis, persistent or chronic cough associated with smoking, asthma, or emphysema, and difficulty urinating due to an enlarged prostate gland.

Additionally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

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

Drug Interactions

The concomitant use of this product with warfarin, a blood-thinning agent, may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and consider dosage adjustments of warfarin as necessary.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease, should avoid using this product. This contraindication extends for a period of two weeks following the discontinuation of the MAOI.

The use of alcohol, sedatives, and tranquilizers in conjunction with this product may enhance drowsiness. Caution is recommended, and patients should be advised to limit the use of these substances to prevent excessive sedation.

Packaging & NDC

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

For dosing, adults and children aged 12 years and older may take 2 softgels with water every 6 hours for nighttime cold and flu relief, and every 4 hours for daytime cold and flu relief.

Caution is advised as excitability may occur, particularly in children. 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 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 medication 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 have liver disease or 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 overall health status and renal capacity.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The active ingredient, acetaminophen, poses a risk of severe liver damage if the total daily dosage exceeds 4,000 mg. Additionally, the risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications that also contain acetaminophen.

Patients are advised to exercise caution regarding alcohol consumption while using this product. Specifically, the risk of severe liver damage increases significantly for individuals who consume three or more alcoholic drinks daily. It is essential for patients with compromised liver function to adhere to these guidelines to mitigate the risk of adverse effects related to liver health. 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, and vigilance is necessary to monitor for any potential adverse effects. The management of an overdose will depend on the specific substance involved and the clinical presentation of the patient.

It is essential to provide comprehensive information regarding the patient's condition to the medical team upon seeking help, including the substance taken, the amount, and the time of ingestion. This information will facilitate appropriate and timely treatment.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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 the use of acetaminophen. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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.

Clinical observations indicate that pain or cough may worsen or persist beyond 7 days, and fever may intensify or last more than 3 days. The presence of redness or swelling, the emergence of new symptoms, or the recurrence of cough accompanied by rash or headache that persists could indicate a serious underlying condition.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use.

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 should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 6 hours for Nighttime Cold & Flu and every 4 hours for Daytime Cold & Flu. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)