Daytime Severe Cold and Flu

Description

This formulation contains acetaminophen, a pain reliever and fever reducer; phenylephrine hydrochloride, a nasal decongestant; dextromethorphan hydrobromide, a cough suppressant; and guaifenesin, an expectorant. The product is presented in a liquid dosage form with a honey flavor. Each bottle contains 12 fluid ounces (355 mL) of the solution.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: sinus congestion and pressure, nasal congestion, minor aches and pains, headache, sore throat, fever, 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 aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs 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. It is imperative to utilize only the dose cup provided with the medication. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL 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, consultation with a healthcare professional is advised before administration. The medication is not recommended for children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of 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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. Verification of MAOI content in current prescriptions should be conducted with a healthcare professional if uncertain.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic drinks daily while using this product.

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 advise patients 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.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough that produces excessive phlegm, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; 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 or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage of 4,000 mg in 24 hours for adults or 5 doses in 24 hours for children. The risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or if the patient consumes three 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 medical assistance immediately.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience symptoms such as 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 fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing a cough with excessive phlegm or trouble urinating due to an enlarged prostate gland should consult a doctor before using this product. Additionally, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

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

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

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. This contraindication extends for a period of two weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a healthcare provider or pharmacist before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered a dosage of 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

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 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 should consult a healthcare professional prior to use, as special monitoring may be required. Dosage adjustments may be necessary for those with reduced renal function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the pharmacokinetics and safety profile of the drug. Monitoring of liver function may be necessary to ensure safe and effective use in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

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

Additionally, users are instructed to stop use and consult a healthcare professional if they experience redness or swelling, the emergence of new symptoms, or if a cough recurs or occurs alongside a rash or persistent headache. These symptoms may indicate a serious condition requiring further evaluation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Additionally, healthcare providers should instruct patients not to exceed the recommended dosage. Clear communication regarding the importance of adhering to the prescribed amount can help prevent potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients must seek immediate medical assistance 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.

Drug Information (PDF)

This file contains official product information for Daytime Severe Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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