Day-Time Cold/Flu Relief

Description

Day Time Cold & Flu Relief is a liquid formulation designed to alleviate symptoms associated with cold and flu. The product contains three active ingredients: Acetaminophen, which serves as a pain reliever and fever reducer; Dextromethorphan HBr, functioning as a cough suppressant; and Phenylephrine HCl, acting as a nasal decongestant. The total volume of the product is 12 fluid ounces (354 mL). It is manufactured by AptaPharma Inc., located at 1533 Union Ave., Pennsauken, NJ 08110. This product is not manufactured or distributed by Procter & Gamble, the owner of the registered trademark Vicks® DayQuil®.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be taken only as recommended, adhering to the overdose warning. A dosage cup or tablespoon (TBSP) should be utilized 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 (2 TBSP) every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL (1 TBSP) every 4 hours. For children aged 4 to under 6 years, consultation with a healthcare professional is advised before administration. The medication is not recommended for children under 4 years of age.

When utilizing both Day Time and Night Time products, it is essential to carefully read each label to ensure correct dosing is achieved.

Contraindications

Use is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks, due to the risk of serious interactions.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated to prevent potential overdose and liver damage.

Consumption of alcoholic beverages is contraindicated, as it may increase the risk of adverse effects.

The product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional, to avoid the risk of prolonged use and associated complications.

Use should not exceed the recommended dosage to prevent overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if the maximum daily dosage of 4 doses within 24 hours is exceeded. Additionally, caution is warranted when this product is taken concurrently with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to 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, it is imperative to consult a healthcare provider promptly.

Patients should be advised to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, new symptoms that arise, a worsening fever lasting more than three days, or pain and cough that persist beyond five days in children or seven days in adults warrant immediate medical consultation. Redness or swelling, as well as a cough that recurs or occurs alongside a rash or headache lasting for an extended period, may indicate a serious underlying condition and should be evaluated by a healthcare professional.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum recommended dosage of four doses in 24 hours, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may lead to liver damage, it is crucial for patients to seek medical help immediately or contact a Poison Control Center, even if no symptoms are present.

Patients should also be alert 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 promptly.

In addition, 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 professional without delay.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, sleeplessness, new symptoms, worsening fever lasting more than three days, or if pain or cough worsens or lasts beyond five days in children or seven days in adults. The presence of redness or swelling, or a cough that returns or occurs with a rash or headache lasting longer than expected, may indicate a serious condition requiring medical evaluation.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or trouble urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or a cough accompanied by excessive phlegm should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs, which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of two weeks following the discontinuation of an MAOI.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Day-Time Cold/Flu Relief (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 15 mL (1 tablespoon) every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

In cases of overdose, it is crucial to seek prompt medical attention for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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 potential adverse effects or changes in therapeutic response, given the lack of detailed information on the use of this medication in the elderly population. Individualized assessment and careful consideration of the patient's overall health status and comorbidities are recommended to ensure safe and effective use.

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 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

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients should avoid the use of other medications containing acetaminophen concurrently, as this may further increase the risk of liver damage.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the risk of liver injury. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose situation and to act swiftly.

In the event of an accidental overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. This is essential for both adults and children, as prompt medical attention is critical regardless of whether any signs or symptoms are immediately apparent.

Monitoring and management of the patient should be initiated as soon as possible to mitigate potential complications associated with liver damage.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health 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

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use, which may manifest as skin reddening, blisters, or rash. In the event of such reactions, it is advised to discontinue use and seek immediate medical assistance.

Additionally, reports indicate that exceeding the recommended dosage of acetaminophen may lead to liver damage. In cases of accidental overdose, prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Healthcare professionals are advised to recommend discontinuation of acetaminophen and consultation with a physician if patients experience symptoms such as nervousness, dizziness, sleeplessness, the emergence of new symptoms, worsening fever lasting more than three days, or pain and cough persisting beyond five days in children or seven days in adults. The presence of redness or swelling, or the recurrence of cough accompanied by rash or persistent headache, may indicate a serious underlying condition requiring further evaluation.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed not to use this product for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. It is important to inform patients not to combine this product with any other medications containing acetaminophen, whether prescription or non-prescription. If patients are unsure about the presence of acetaminophen in their other medications, they should seek guidance from a doctor or pharmacist.

Patients should be advised to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to seek medical advice if new symptoms arise, if fever worsens or persists beyond 3 days, or if pain or cough intensifies or lasts longer than 5 days in children or 7 days in adults. Patients should also be informed to stop use and consult a doctor if they notice any redness or swelling, or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be cautioned against exceeding the recommended dosage and should be made aware of the overdose warning. They should also be advised to avoid alcoholic beverages while using this product.

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, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients with a cough accompanied by excessive phlegm should be advised to consult a doctor. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with a doctor or pharmacist.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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