Multi-Symptom Daytime

Description

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl are the active pharmaceutical ingredients in this formulation. The product is presented in the form of liquid-filled capsules, designed for oral administration. Each capsule contains a specific dosage of the active ingredients, which are utilized for their analgesic, antitussive, and decongestant properties, respectively. The formulation ensures the stability and bioavailability of the active components, facilitating effective therapeutic outcomes.

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 physician 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:

• 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, and their interaction with this product may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• Additionally, the product should not be used in excess of the recommended dosage.

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 (the maximum daily amount), 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, which can manifest as skin reddening, blisters, or rash. Healthcare professionals should advise patients to seek medical attention promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

In cases of overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center or seek medical help right away, regardless of whether signs or symptoms are present, as quick intervention is critical for both adults and children.

General precautions must be observed. This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should verify with their healthcare provider or pharmacist if they are unsure about their prescription drugs.

Before using this product, patients should consult a healthcare professional 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, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, or emphysema. Furthermore, patients taking the anticoagulant Warfarin should seek advice from a healthcare professional prior to use.

Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

Healthcare professionals should instruct patients to discontinue use and seek medical advice 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 condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 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 severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised that patients seek medical attention promptly.

Patients are instructed to discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Prior to using this product, patients should consult a healthcare provider if they have a history of 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 or chronic conditions such as smoking, asthma, or emphysema. Additionally, patients taking the blood-thinning medication Warfarin should seek advice from a doctor or pharmacist before use.

An overdose warning is in place, as taking more than the directed amount can lead to serious health complications. In the event of an overdose, it is critical for patients to seek immediate medical assistance or contact a Poison Control Center, even if no signs or symptoms are initially apparent. Quick medical attention is essential for both adults and children.

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.

Pharmacodynamic interactions should be considered when this medication is administered alongside monoamine oxidase inhibitors (MAOIs). It is advised that this medication not be used in conjunction with any MAOI, including those prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI.

Additionally, caution is warranted when this medication is used in patients taking warfarin, a blood-thinning agent. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently on warfarin therapy to ensure appropriate monitoring and management of potential interactions.

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

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. 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.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 taking this product in conjunction with other medications that contain acetaminophen, as this can further increase the risk of liver damage.

It is also advised that patients with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as this may exacerbate the risk of liver injury.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

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

Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the risks associated with overdosage and improve patient outcomes.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

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

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product in conjunction with any other medication 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.

Patients must be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. MAOIs are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek clarification from a healthcare professional.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days. If fever worsens or lasts longer than three days, or if redness or swelling occurs, patients should also be directed to contact their healthcare provider.

Patients should be informed to stop use and consult a doctor if new symptoms arise or if a cough returns, particularly if it is accompanied by a rash or a headache that persists, as these may indicate a serious condition. It is crucial to emphasize that patients should not exceed the recommended dosage when using this product.

Before initiating treatment, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have 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 those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a doctor prior to use. Furthermore, patients taking the blood-thinning medication Warfarin should seek advice from 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 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, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to swallow 2 softgels with water every 4 hours. For children aged 4 to under 12 years, it is recommended to consult a doctor before use, while the medication is not advised for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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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