Day Time Cold and Flu Relief

Description

This formulation contains Acetaminophen at a dosage of 325 mg, serving as a pain reliever and fever reducer. It also includes Dextromethorphan HBr at 10 mg, which functions as a cough suppressant, and Phenylephrine HCl at 5 mg, acting as a nasal decongestant. The product is presented in an original flavor, is alcohol-free, and does not contain antihistamines. It is indicated for use in individuals aged 6 years and older.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates 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

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours.

For children aged 4 to under 6 years, it is advised to consult a physician before administration. The product is not recommended for use in children under 4 years of age.

It is important to note that no more than 4 doses should be taken within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product for convenience.

When using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure correct dosing and avoid potential overdosing.

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 is due to potential interactions that may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

Additionally, it is contraindicated to exceed the recommended dosage, as this may lead to adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients that the maximum daily dosage for adults is 4 doses (30 mL each) within a 24-hour period, and for children, it is 4 doses (15 mL each). Caution is warranted if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

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

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, a sore throat that is severe, persists for more than 2 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 nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults, as well as fever that worsens or lasts more than 3 days. Redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs alongside a rash or headache that persists should also prompt medical evaluation, as these may indicate a serious condition.

Drug Interactions

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

Pharmacodynamic interactions should be considered when this medication is administered alongside monoamine oxidase inhibitors (MAOIs). It is advised to avoid the use of this medication in patients currently taking MAOIs or within 2 weeks of discontinuing such treatment, as this may lead to serious adverse effects.

Additionally, caution is warranted when this medication is used in conjunction with warfarin, a commonly prescribed anticoagulant. Patients are advised to consult a healthcare professional prior to use if they are currently taking warfarin, as this combination may necessitate careful monitoring of coagulation parameters to prevent potential bleeding complications.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning associated with the use of this medication; if a child takes more than 4 doses (15 mL each) within a 24-hour period, medical advice should be sought. Additionally, caregivers should be instructed to stop use and consult a doctor if the child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

In cases of suspected overdose, immediate medical attention is critical for pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: an adult takes more than 4 doses (30 mL each) of acetaminophen within a 24-hour period, a child takes more than 4 doses (15 mL each) in the same timeframe, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to use. In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. 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.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Healthcare professionals should be vigilant in assessing the situation and providing appropriate interventions.

Potential Symptoms

While specific symptoms of overdose are not detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment following an overdose.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate standard emergency protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly impact patient outcomes.

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 limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage of the medication, as taking more than the prescribed amount may lead to liver damage. In the event of an overdose, patients must seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. It is crucial for both adults and children to receive prompt medical attention, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop using the medication and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. If fever intensifies or lasts more than 3 days, or if any redness or swelling occurs, patients should also stop use and contact a healthcare professional. New symptoms that arise during treatment should prompt a discussion with a doctor, as these may indicate a serious condition. Patients should be particularly vigilant if a cough returns or occurs alongside a rash or persistent headache.

Before initiating treatment, patients should be encouraged to consult a healthcare provider if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or are on a sodium-restricted diet. Those experiencing difficulty urinating due to an enlarged prostate gland, or who have a persistent or chronic cough associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should 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 a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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