Daytime Cold and Flu

Description

Acetaminophen, at a dosage of 325 mg, serves as a pain reliever and fever reducer. Dextromethorphan HBr is included at a concentration of 10 mg, functioning as a cough suppressant. The formulation contains no added alcohol. The product features a tamper-evident design, and it is advised not to use the product if the printed safety seal around the dosage cup or under the cap is broken or missing.

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, cough due to minor throat and bronchial irritation, and for the temporary reduction of fever.

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 utilizing both Day Time and Night Time formulations, healthcare professionals should ensure that patients 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.

This product should not be used in individuals with a known allergy to acetaminophen, as it may provoke an allergic reaction.

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

Additionally, it is essential to adhere to the recommended dosage and not exceed it.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4 doses (30 mL each) within a 24-hour period, which is the maximum daily amount. For children, the maximum daily amount is 4 doses (15 mL each) in 24 hours. Caution is advised if this product is taken concurrently with other medications containing acetaminophen. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken prior to use. Patients should be advised to consult a doctor if they have liver disease, respiratory issues such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (especially associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm. Additionally, it is advisable to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

In cases of 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 rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a physician if any of the following occur: pain or cough worsens or persists beyond 5 days in children or 7 days in adults; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4 doses (30 mL each) within a 24-hour period, or if a child takes more than 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further heightened when 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, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek immediate 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 are advised to consult a healthcare professional promptly. Additionally, patients should stop use and contact a doctor if pain 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 occurs, if new symptoms arise, or if a cough recurs with a rash or headache that persists.

Patients should not use acetaminophen if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks, if they are allergic to acetaminophen, or if they are using any other drug containing acetaminophen. It is advisable for patients to consult a doctor before use if they have liver disease, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough, or a cough that produces excessive phlegm. Furthermore, patients taking the blood-thinning medication warfarin should seek guidance from a healthcare professional prior to use.

Overdose of acetaminophen can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently on warfarin therapy. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hbr). 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 every 4 hours, with a maximum of 4 doses (15 mL each) within a 24-hour period. For children aged 4 to under 6 years, it is advised to consult a doctor before administration. The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if a child's pain or cough worsens or persists for more than 5 days, or if a fever worsens or lasts longer than 3 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 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 currently no available data regarding the excretion of this medication 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this maximum is 4 doses (30 mL each) within a 24-hour period, while for children, it is 4 doses (15 mL each) in the same timeframe. Additionally, patients should be advised against taking this product concurrently with other medications containing acetaminophen, as this can increase the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should exercise caution, as this may exacerbate the risk of liver injury when using acetaminophen.

In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Patients and caregivers should be informed to contact a Poison Control Center (1-800-222-1222) without delay, as 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 significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and to act promptly.

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 essential, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of vigilance even in the absence of noticeable signs or symptoms.

Timely medical attention can be critical in managing the potential consequences of an overdose, and healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary steps to take in such situations.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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, 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, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, they should stop use and seek medical advice if fever intensifies or lasts more than 3 days, if there is any redness or swelling, or if new symptoms arise. Patients should also be informed to stop use and consult a healthcare professional if a cough returns or occurs alongside a rash or a headache that persists.

It is important for patients to consult a doctor before using this medication if they have liver disease, breathing problems such as emphysema or chronic bronchitis, 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 prior to use. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) should consult a healthcare provider before using the medication. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist prior to initiation.

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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