Multi-Symptom Daytime

Description

The formulation contains three active ingredients: acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride. Acetaminophen serves as a pain reliever and fever reducer, while dextromethorphan hydrobromide acts as a cough suppressant. Phenylephrine hydrochloride functions as a nasal decongestant. The product is presented in the form of liquid-filled softgels, with a total of 48 softgels per package.

Uses and Indications

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

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 4 hours.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing guidance.

The medication is not recommended for use in children under 4 years of age.

When using both Daytime and Nighttime softgels, it is essential to carefully read each label to ensure correct dosing and avoid exceeding the recommended limits.

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, this product is contraindicated 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 any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

It is also important to adhere to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, with symptoms that can include skin reddening, blisters, and rash. Healthcare professionals should advise patients to seek immediate medical attention if they experience any of these symptoms.

Patients should be instructed to consult a physician if they have a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

It is critical to emphasize that taking more than the directed dosage can result in serious health complications. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm (mucus). Additionally, patients with a persistent or chronic cough, such as that seen in smoking, asthma, or emphysema, should consult a healthcare provider before use. It is also advisable for patients taking the anticoagulant Warfarin to seek guidance from a doctor or pharmacist prior to using this product.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; 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.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly if patients exceed the maximum daily dosage of four doses within a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using the product.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash.

Patients are advised to seek medical attention if they experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Additionally, patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

It is important for patients to consult a doctor before using this product if they have pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, or emphysema should also seek medical advice prior to use.

Furthermore, patients taking the blood-thinning medication Warfarin should consult a healthcare professional before using this product.

Taking more than the recommended dosage can lead to serious health complications. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant Warfarin should consult a healthcare professional 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 Multi-Symptom Daytime (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 4 hours, with a maximum of 4 doses within 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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 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. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Patients with known liver disease should consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals recognize the potential risks associated with overdosage and act promptly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick intervention is crucial, as the severity of symptoms may not be immediately apparent.

Both adults and children require urgent medical attention following an overdose, regardless of whether any signs or symptoms are observed. This proactive approach is essential to mitigate potential health risks and ensure patient safety.

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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

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 drug 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 for clarification.

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 ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if they experience symptoms such as nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days. Additionally, they should be advised to contact a doctor if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough returns or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

While using this product, patients should be reminded 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, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Finally, patients taking the blood-thinning medication Warfarin should be advised to consult a doctor or pharmacist before using this product to avoid potential interactions.

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 room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat to ensure the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are instructed to swallow 2 softgels with water every 4 hours for oral administration. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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