Daytime Cold and Flu

Description

Acetaminophen, with a dosage of 325 mg, is combined with Dextromethorphan HBr at 10 mg and Phenylephrine HCl at 5 mg in this formulation. The product is alcohol-free and does not contain antihistamines, making it suitable for non-drowsy use. It is indicated for individuals aged 6 years and older. This product is manufactured by PL Developments, located at 11865 S. Alameda St, Lynwood, CA 90262.

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

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 not to exceed 4 doses within a 24-hour period. The dosing cup provided with the product must be used for measurement; no other dosing devices should be utilized. The dosing cup should be kept with the product to ensure proper administration.

When using both Day Time and Night Time formulations, healthcare professionals should instruct patients to carefully read each label to confirm the correct dosing.

Contraindications

Use of this product 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. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other medication containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, it is important not to exceed the recommended dosage of this product.

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 under the following circumstances:

• An adult should not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, as this represents the maximum daily amount.

• A child should not exceed 4 doses (15 mL each) in a 24-hour period.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen.

• Adults consuming 3 or more alcoholic drinks daily while using this product are at heightened risk for liver damage.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

Overdose of acetaminophen can lead to significant liver damage. In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur:

• Nervousness, dizziness, or sleeplessness

• Worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults

• Fever that worsens or persists for more than 3 days

• Presence of redness or swelling

• Emergence of new symptoms

• Recurrence of cough accompanied by rash or headache lasting for an extended period

These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur if an adult takes more than 4 doses (30 mL each) of acetaminophen in a 24-hour period, which is the maximum daily amount. Similarly, a child should not exceed 4 doses (15 mL each) in 24 hours. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product. In the event of an overdose, which may result from exceeding the recommended dose, patients should seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should also be alert to the possibility of severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical help immediately.

In addition, patients are advised to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Other adverse reactions that warrant medical consultation include nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or lasts more than 3 days; presence of redness or swelling; new symptoms; or a cough that recurs or is accompanied by a rash or headache. These symptoms could indicate a serious underlying condition.

Patients should remain vigilant and report any concerning symptoms to their healthcare provider to ensure safe and effective use of the product.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication if they are currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for conditions such as depression, certain psychiatric disorders, or Parkinson's disease.

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 prior to using this medication if they are currently taking warfarin, as monitoring may be necessary to ensure safe and effective use.

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 the liver warning, which indicates that if a child takes more than 4 doses (15 mL each) within a 24-hour period, medical advice should be sought. Additionally, if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days, it is important to stop use and consult a doctor.

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

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 lack of data 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 critical to adhere to the recommended dosing guidelines to prevent severe liver damage. For adults, the maximum daily dosage should not exceed 4 doses (30 mL each) within a 24-hour period. For children, the maximum is 4 doses (15 mL each) in the same timeframe.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Additionally, caution is warranted for individuals who consume three or more alcoholic drinks daily while using this product, as this may increase the risk of liver damage.

In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious 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. Prompt intervention is crucial, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe liver injury.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients that taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription includes an MAOI, they should consult with their doctor or pharmacist prior to use.

It is important to counsel patients against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are unsure whether a drug contains acetaminophen, they should seek guidance from a healthcare professional.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use 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 worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also stop use and contact a healthcare provider. New symptoms or a recurrence of cough accompanied by a rash or persistent headache should prompt patients to seek medical attention, as these may indicate a serious condition.

When 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, a sodium-restricted diet, 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 experiencing a cough with excessive phlegm should consult a healthcare professional. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with their 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 a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal 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.

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