Daytime Severe Cold and Flu Relief

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and flu. Specifically, it addresses nasal congestion, sinus congestion and pressure, minor aches and pains, headache, fever, sore throat, and cough due to minor throat and bronchial irritation.

Additionally, this drug reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose. It also helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus and making cough more productive.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours, also not exceeding 4 doses in a 24-hour timeframe. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before administration. The product is not recommended for 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 instruct 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:

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.

Patients are also advised not to exceed the recommended dosage.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, while children should not take more than 4 doses (15 mL each) in the same timeframe. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen. Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blistering, or rash. Should any of these symptoms occur, patients must 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 healthcare provider promptly.

General precautions should be taken for individuals with specific health conditions. Patients should be instructed to consult a physician prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, those with a persistent or chronic cough, such as that seen in smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. It is important to consult a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a 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 new symptoms arise, medical consultation is necessary. Patients should also seek medical advice if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 4 doses (30 mL each) in 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, which may manifest as skin reddening, blistering, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should consult a healthcare provider if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Patients are advised to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults; if new symptoms arise; if fever worsens or lasts more than 3 days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious condition.

Before using this product, patients should consult a healthcare professional if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, those with a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In cases of overdose, which can lead to serious liver damage, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) or seek medical help right away, even if no signs or symptoms are present. Quick intervention is critical for both adults and children.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication, as concurrent use may elevate the risk of bleeding.

No additional drug interactions or laboratory test interactions have been identified. Therefore, routine monitoring or dosage adjustments are not specified beyond the aforementioned consideration with warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Severe Cold and Flu Relief (acetaminophen dextromethorphan hbr guaifenesin, phenylephrine hcl). 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, if symptoms such as pain, nasal congestion, or cough worsen or persist for more than 5 days, it is important to stop use and consult a doctor.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Quick medical attention is crucial for pediatric patients, even if no signs or symptoms of overdose are apparent.

Geriatric Use

There is no specific information 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 the safety of both the mother and the developing fetus or nursing 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 mothers.

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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed the maximum daily dosage of acetaminophen, which is 4 doses (30 mL each) for adults and 4 doses (15 mL each) for children within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen to prevent cumulative toxicity.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, adults consuming three or more alcoholic drinks daily should refrain from using this product, as this may significantly increase the risk of liver damage.

In the event of an overdose, which can lead to serious liver damage, immediate medical assistance should be sought. Patients or caregivers should 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

Taking more than the recommended dose of this medication can lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical attention is crucial, particularly for adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly impact the outcome and mitigate potential complications associated with overdose.

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

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blistering, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to serious liver damage. In the event of an overdose, patients should 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 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 instruct patients not to 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. New symptoms, worsening fever lasting more than 3 days, or the presence of redness or swelling should also prompt a consultation with a healthcare provider. Patients should be made aware that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

When using this product, patients must be reminded not to exceed the directed 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 cough accompanied by excessive phlegm or those with a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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 Severe Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)