Daytime Cold and Flu

Description

DayTime Cough and Cold Capsules are provided in a bulk shipment containing 4000 capsules. The product is identified by the National Drug Code (NDC) 53345-004-01. It is essential to inspect the shipment immediately upon receipt. This product is intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the capsules should be protected from heat, humidity, and light, and refrigeration is not recommended.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: cough due to minor throat and bronchial irritation, nasal congestion, sore throat, headache, minor aches and pains, and fever.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

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 to swallow two softgels 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 both NIGHTTIME and 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:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions and adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

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 cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

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

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or insomnia; if symptoms worsen or persist beyond 5 days for children or 7 days for adults; if fever intensifies or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These may indicate a serious underlying condition requiring further evaluation.

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 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 liver disease, heart disease, diabetes, thyroid disease, high blood pressure, a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland should consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should also seek advice from a healthcare provider prior to use.

While using this product, patients must adhere strictly to the directed dosage. They should discontinue use and consult a doctor if they experience 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 usual, as these may indicate a serious condition.

An overdose of this product can lead to serious health complications. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

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, which can lead to severe liver damage.

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 for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises or other serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to mitigate the risk of increased bleeding.

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 healthcare professional before use. The medication is not recommended for children under 4 years of age.

In pediatric patients, if symptoms worsen or persist for more than 5 days, medical advice should be sought. For adults, symptoms lasting more than 7 days also warrant consultation with a healthcare provider.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should evaluate the individual circumstances of each patient to ensure the safety of both the mother and the fetus.

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 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 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 lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks daily while using this product to mitigate the risk of liver injury.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

Taking more than the recommended dosage 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 may not be immediately apparent.

For both adults and children, rapid medical attention is essential, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the risks associated with overdosage and improve patient outcomes.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis, angioedema, and urticaria. Additional adverse reactions reported encompass liver injury, gastrointestinal bleeding, and renal impairment. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Furthermore, cases of serotonin syndrome have been reported in patients using dextromethorphan in conjunction with other serotonergic medications. The safety profile of the product may evolve as further data becomes available.

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 stopped taking an MAOI within the past two weeks. Patients who are unsure if their prescription medication contains an MAOI should seek guidance from a healthcare professional.

Patients should be advised to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to stop use and seek medical advice 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 redness or swelling occurs, patients should also be directed to stop use and contact a healthcare provider. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, a cough associated with excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

Patients should be advised that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 4 hours. For children aged 4 to under 12 years, it is recommended to consult a doctor before use, while the medication is not suitable for children under 4 years of age.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, 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 Daytime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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