Basic Care Daytime Nighttime Cold and Flu

Description

This formulation contains Acetaminophen, Phenylephrine HCl, and Dextromethorphan HBr, serving as a pain reliever, fever reducer, cough suppressant, and nasal decongestant. It is alcohol-free and available in an original flavor. Additionally, the formulation includes Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate, functioning as a pain reliever, fever reducer, cough suppressant, and antihistamine, with an alcohol content of 10% and a cherry flavor. The product is packaged in 2 to 12 fluid ounce (355 mL) bottles, with a total volume of 24 fluid ounces (1.5 pt) or 710 mL.

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 adhere strictly to the prescribed dosage and administration guidelines. The medication is to be taken only as directed, and healthcare professionals should refer to the Overdose warning for further information.

The provided dose cup must be utilized for accurate measurement. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is contraindicated for children under 4 years of age; therefore, use in this age group is not recommended.

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, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under specific circumstances. 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 a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, patients with a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, should seek medical advice before use.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent.

Patients are advised to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, 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 consultation is necessary. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting beyond a short 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 5 doses in 24 hours, the product is used in conjunction with other medications containing acetaminophen, or if an adult consumes 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 any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if they experience symptoms such as 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 acetaminophen, individuals with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, patients with a cough that produces excessive phlegm or those with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, should seek medical advice prior to use.

It is also recommended that patients consult 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 contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as quick intervention is critical for both adults and children.

Drug Interactions

Co-administration of this product with any other medication 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.

The use of this product in conjunction with prescription monoamine oxidase inhibitors (MAOIs) is not recommended. Patients currently taking an MAOI or who have discontinued an MAOI within the past two weeks should seek guidance from a healthcare provider prior to using this product. It is essential to confirm whether any current prescription medications contain an MAOI.

Caution is advised when using this product alongside warfarin, a commonly prescribed anticoagulant. Patients should consult their healthcare provider or pharmacist before initiating this combination to ensure safe use.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Patients should be informed of this risk and advised to exercise caution when engaging in activities that require alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care Daytime 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. For children under 4 years, the product is contraindicated and should not be used.

In terms of dosing, adults and children aged 12 years and older may take 30 mL every 6 hours for nighttime cold and flu symptoms. Children aged 6 to under 12 years are advised to take 15 mL every 4 hours for daytime cold and flu relief.

It is important to note that quick medical attention is essential in cases of overdose for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the fetus or 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of their condition, as reduced kidney function may influence the pharmacokinetics and safety profile of the medication.

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 regarding the use of this product, as compromised liver function may affect the metabolism and clearance of the medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this patient population.

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.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with acetaminophen use. Reports indicate that acetaminophen may lead to severe skin reactions, characterized by symptoms such as 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 noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Healthcare professionals should be alerted if pain or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days. 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, warranting further evaluation.

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 medical attention is crucial for both adults and children, even if no signs or 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 an MAOI within the past two weeks. Patients should be encouraged to ask 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 for more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Patients should also be informed to seek medical advice if their cough returns or is accompanied by a rash or headache that lasts, 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 may also be a side effect. They should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. Patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should be advised to speak with their doctor or pharmacist if they are taking sedatives, tranquilizers, or 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

Patients aged 12 years and older are advised to take 30 mL of the medication every 6 hours for Nighttime Cold & Flu and every 4 hours for Daytime Cold & Flu. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours for Daytime Cold & Flu. For children aged 4 to under 12 years, it is recommended to consult a doctor regarding Nighttime Cold & Flu, while the medication is not to be used in children under 4 years for either formulation.

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, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt 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 Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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