Daytime Cold and Flu

Description

DayTime Cold and Flu Capsules are provided in a bulk shipment containing 4000 capsules, identified by NDC No: 53345-025-01. Upon receipt, immediate inspection is required. These capsules are intended solely for further manufacturing, processing, or repackaging. It is essential to protect the product from heat, humidity, and light, and refrigeration is not recommended. The optimal storage conditions are between 15-30°C (59-86°F).

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, nasal congestion, sore throat, headache, minor aches and pains, 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 four hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing guidance. The medication is not recommended for children under 4 years of age.

When using other nighttime or daytime products, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

• Exceeding the recommended dosage is contraindicated to prevent potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

In addition, healthcare professionals should advise patients to seek medical attention if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients are advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, individuals with a persistent or chronic cough, such as those with smoking history, asthma, or emphysema, should also seek medical advice. It is important to consult a doctor or pharmacist before use if the patient is taking the anticoagulant warfarin.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or insomnia. Furthermore, if symptoms worsen or persist 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 returning cough accompanied by a rash or headache that persists are also indicators of a potentially serious condition, warranting immediate consultation with a healthcare professional.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within 24 hours, take this product in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of such medication. Patients uncertain about the presence of an MAOI in their prescription should seek guidance from a healthcare professional.

Patients with a history of liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or urinary difficulties due to an enlarged prostate gland should consult a doctor before using this product. Furthermore, individuals experiencing a cough associated with excessive phlegm or a persistent cough due to smoking, asthma, or emphysema should also seek medical advice prior to use. Patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product.

While using this product, patients must adhere strictly to the directed dosage. They should discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness, if symptoms worsen or persist beyond 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.

Patients should be aware that taking more than the recommended dosage can lead to serious health complications. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a doctor before use. The product is not recommended for children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 4 hours.

If symptoms worsen or persist for more than 5 days, or if fever worsens or lasts more than 3 days, a consultation with a healthcare professional is advised.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare 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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize this risk:

• Patients must not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product.

• Caution is advised against the concurrent use of other medications containing acetaminophen, as this may lead to unintentional overdose and subsequent liver damage.

• Consumption of 3 or more alcoholic drinks daily while using this product is strongly discouraged, as it may exacerbate the risk of liver injury.

Before using this product, patients with a history of liver disease should consult a healthcare professional to evaluate the appropriateness of use and to discuss any necessary monitoring or dosage adjustments.

Overdosage

Taking more than the recommended dosage of the medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the severity of symptoms can vary significantly between adults and children.

It is important to note that even in the absence of observable signs or symptoms, children may still be at risk and require urgent medical evaluation. Quick medical attention is essential to mitigate potential adverse effects and ensure appropriate management of the situation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be informed to stop using the product and consult a doctor if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If a fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should also be advised to seek medical attention. New symptoms that arise during treatment should prompt a consultation with a healthcare provider.

Patients should be cautioned to stop use and consult a doctor if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition. When using this product, patients must adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

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 room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)