Daytime Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, nasal congestion, fever, sinus 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, not exceeding 4 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours, also not to exceed 4 doses in a 24-hour period. For children aged 4 to under 6 years, it is recommended to consult a physician before administration. The product is not intended for use in children under 4 years of age.

It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times. When using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm correct dosing and avoid potential overdose.

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), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults should not exceed 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 increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Severe skin reactions have been 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 immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. Overdosing on acetaminophen can lead to liver damage; therefore, in cases of overdose, immediate medical attention is essential. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

While using this product, it is crucial not to exceed the recommended dosage.

Patients should be instructed to stop taking the product and contact their 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 underlying 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 indicative of such reactions 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.

Participants are advised to stop use and consult a healthcare professional 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. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting beyond a short duration may indicate a serious condition requiring prompt evaluation.

An overdose of acetaminophen can lead to liver damage. Patients are urged to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) if they suspect an overdose, even in the absence of noticeable signs or symptoms. Quick medical attention is critical for both adults and children in such cases.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and over may be administered 30 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In 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: if a child takes more than 4 doses of 15 mL each within a 24-hour period, there is a risk of severe liver damage. 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.

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 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 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 exercise caution 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 amount is 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, the risk of liver damage increases if the product is taken in conjunction with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

In the event of an overdose, which may lead to liver damage, 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 signs or symptoms.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Recommended Actions In the case of suspected overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt intervention is crucial, as quick medical attention can mitigate the risks associated with overdose for both adults and children, even in the absence of noticeable symptoms.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. The importance of early intervention cannot be overstated, as it plays a critical role in the overall outcome for the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. 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 be encouraged to consult a doctor or pharmacist.

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 last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. If fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also be advised to seek medical attention.

Patients should be made aware that new symptoms may arise, and they should stop use and consult a doctor if these occur. They should be particularly vigilant for a returning cough or a cough accompanied by a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients must be cautioned not to 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, high blood pressure, thyroid disease, diabetes, 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 should be advised to consult a doctor if they have a cough that produces excessive phlegm (mucus) or if they are taking the blood-thinning medication warfarin.

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 20-25°C (68-77°F). 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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