Daytime Severe Cold and Flu

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it provides relief from minor aches and pains, headache, sore throat, nasal congestion, and cough. Additionally, this drug helps to loosen phlegm (mucus) and thin bronchial secretions, thereby making coughs more productive. It also temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the total dosage should not exceed 10 caplets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which necessitates careful monitoring due to the potential for severe liver damage. The maximum recommended daily dosage is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. Healthcare professionals should advise patients against exceeding 4,000 mg of acetaminophen in a single day, using other medications that also contain acetaminophen concurrently, or consuming three or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists beyond two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Patients are advised to stop use and consult a physician if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever that intensifies or persists beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache warrant immediate medical evaluation, as these may indicate a serious underlying condition.

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

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed the maximum daily dose of 4,000 mg of acetaminophen, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or lasts more than three days; the presence of redness or swelling; the emergence of new symptoms; or a cough that recurs or occurs with a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the anticoagulant effect.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

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. It is important to assess the potential risks and benefits associated with its 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose for patients is limited to 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the use of additional acetaminophen-containing products. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential risks associated with excessive intake of this product. The maximum recommended daily dose is 10 caplets, which equates to 3,250 mg of acetaminophen within a 24-hour period. Exceeding this dosage can lead to severe liver damage, particularly if the total intake of acetaminophen surpasses 4,000 mg in a single day.

Healthcare professionals should be aware that the risk of severe liver damage is heightened when this product is taken concurrently with other medications that also contain acetaminophen. Therefore, it is essential to review all medications a patient may be taking to prevent unintentional overdose.

Additionally, the consumption of three or more alcoholic drinks daily while using this product significantly increases the risk of liver damage. Patients should be advised to limit alcohol intake to mitigate this risk.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should monitor liver function and consider appropriate management strategies, which may include the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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.

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 about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

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 advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should also be advised to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists for more than seven days. If fever worsens or lasts longer than three days, or if any redness or swelling occurs, patients should be directed to consult a healthcare professional. New symptoms or a recurrence of cough accompanied by a rash or persistent headache should also prompt a discussion with a doctor, as these may indicate a serious condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and advise 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, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough that produces excessive phlegm should also be encouraged to seek medical advice prior to use.

Finally, patients taking the blood-thinning medication warfarin should be advised to consult with 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 should be stored at a controlled room temperature of 25ºC (77ºF). Temporary excursions are permissible within the range of 15ºC to 30ºC (59ºF to 86ºF).

Care should be taken to ensure that the product is kept in its original container to maintain its integrity and efficacy. Special handling requirements should be observed to prevent exposure to extreme temperatures outside the specified range.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

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.

View product document (PDF)