Daytime Cold and Flu

Description

No description information is available for the drug.

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

Adults and children aged 12 years and older are advised to administer 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 physician 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.

Healthcare professionals should ensure that patients do 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 facilitate accurate measurement.

When utilizing both Day Time and Night Time formulations, it is crucial to carefully read each label to confirm the correct dosing instructions.

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.

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

Exceeding the recommended dosage is contraindicated, as it may lead to adverse effects.

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 the following conditions are met: an adult consumes more than 4 doses (30 mL each) of acetaminophen within a 24-hour period, a child exceeds 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 beverages daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or 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, particularly if it persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare provider promptly.

Patients should be advised to stop use and consult a physician if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, or if fever worsens or persists beyond 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache lasting should also prompt immediate consultation, as these may indicate a serious underlying condition.

In the event of an overdose, it is critical to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Severe adverse reactions associated with the use of acetaminophen include the potential for severe liver damage, particularly if the maximum daily dosage is exceeded. Adults should not take more than 4 doses (30 mL each) in 24 hours, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further increased 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 risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if new symptoms arise. A cough that recurs or occurs with a rash or headache that persists may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or those on a sodium-restricted diet should consult a doctor before use. This also applies to individuals with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, as well as those experiencing cough accompanied by excessive phlegm. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist prior to using acetaminophen.

In cases of overdose, which may result in liver damage, immediate medical attention is critical. Patients should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent. Quick intervention is essential for both adults and children in such situations.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. Co-administration of these agents can potentially alter the anticoagulant effect of warfarin, leading to an increased risk of bleeding. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are currently taking warfarin. Monitoring of INR levels may be warranted to ensure therapeutic efficacy and safety.

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, 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

Elderly patients may not have specific information regarding the use of this medication, including 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 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 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 the following dosing limits: adults should not take more than 4 doses (30 mL each) of acetaminophen in a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, adults consuming 3 or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the potential for liver damage.

In the event of an overdose, which may occur if the recommended dose is exceeded, 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

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance promptly. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Quick action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be immediately apparent, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of liver impairment and be prepared to initiate appropriate management protocols.

Management Procedures Upon confirmation of an overdose, healthcare providers should follow established guidelines for the management of liver toxicity. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the overdose and the patient's clinical status.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

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 about the importance of adhering to the recommended dosage, emphasizing that exceeding this dosage may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to 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 intensifies or lasts more than 3 days, or if there is any redness or swelling, patients should also be encouraged to consult a healthcare professional.

Patients should be made aware that new symptoms warrant a discussion with their doctor, particularly if a cough recurs or is accompanied by a rash or persistent headache. It is essential for patients to consult a doctor before using the medication if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or are on a sodium-restricted diet. Those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or who experience cough with excessive phlegm, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should be advised to 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 Daytime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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