Daytime Cold and Flu

Description

Acetaminophen, at a dosage of 325 mg, serves as a pain reliever and fever reducer. The formulation also includes Dextromethorphan HBr at 10 mg, which acts as a cough suppressant, and Phenylephrine HCl at 5 mg, functioning as a nasal decongestant. This product is intended for use by individuals aged 6 years and older and is free from antihistamines. The product features a tamper-evident design, with a warning to not use if the printed safety seal around the dosage cup or under the cap is broken or missing. It is distributed by Walmart Inc., located in Bentonville, AR 72716.

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

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is important to consult a healthcare professional for children aged 4 to under 6 years, as specific dosing instructions should be obtained. The product is not recommended for use in children under 4 years of age.

Patients should not exceed 4 doses within a 24-hour period. It is essential to measure the dosage using only 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 to ensure proper measurement. When using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm correct dosing.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

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 significantly if an adult exceeds 4 doses (30 mL each) of acetaminophen within a 24-hour period, or if a child exceeds 4 doses (15 mL each) in the same timeframe. Additionally, caution is warranted if the product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must 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.

General precautions should be taken prior to use. Patients should be encouraged to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, a sodium-restricted diet, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), cough with excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Furthermore, 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 crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, 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 advice should be sought. Signs of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts should also prompt immediate consultation, as these may indicate a serious underlying condition.

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 heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the 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 may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice 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 is accompanied by a rash or headache that persists may indicate a serious condition requiring medical evaluation.

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.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, 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 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 a liver warning indicating that if a child takes more than 4 doses (15 mL each) within a 24-hour period, medical advice should be sought. Additionally, caregivers should stop use and consult a doctor if the child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

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 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 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 absence of 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 closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the following conditions are met: an adult takes more than 4 doses (30 mL each) of acetaminophen in 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.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical 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. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of prompt evaluation and management, even in the absence of overt signs or symptoms of overdose.

Healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary steps to take in the event of an overdose, reinforcing the importance of adhering to the prescribed dosage.

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

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 consult a doctor or pharmacist for clarification.

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 past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should 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, or if redness or swelling occurs, patients should also stop use and contact a healthcare professional. 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 not exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or if they are on a sodium-restricted diet. 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 experiencing a cough with excessive phlegm or those who have difficulty urinating due to an enlarged prostate gland should consult a healthcare provider prior to using this product. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before use.

Storage and Handling

The product is supplied in specific packaging configurations, with relevant NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

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)