Daytime Cold and Flu Mini Softgels

Description

No description information is available for the specified drug.

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

The medication should be taken only as directed, with a maximum dosage of 8 softgels within a 24-hour period. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician before administration. The use of this medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. This is due to the potential for serious drug interactions that may lead to adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is 10 Softgels within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as this can exacerbate the risk of liver injury. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the likelihood of liver damage.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients are instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider without delay.

Patients should be instructed to stop use and seek medical advice if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; any signs of redness or swelling; the emergence of new symptoms; or if a cough recurs, especially when accompanied by a rash or headache that lasts.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are initially apparent. Prompt intervention is essential for both adults and children.

Side Effects

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

Severe liver damage may occur if patients exceed the maximum daily dosage of 10 Softgels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as they should consult a doctor promptly.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than 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.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Mini Softgels (acetaminophen, dextromethorphan hbr, phenylephrine hcl). 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 medication is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 8 softgels in a 24-hour period.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 10 Softgels within a 24-hour period. Exceeding this dosage may lead to significant hepatic injury, particularly in individuals with compromised liver function.

Additionally, patients should be aware that taking acetaminophen in conjunction with other medications containing acetaminophen can further increase the risk of severe liver damage. It is essential for patients to review all medications with their healthcare provider to avoid unintentional overdose.

Patients with hepatic impairment are also advised to limit alcohol consumption. The risk of severe liver damage is heightened if they consume three or more alcoholic drinks daily while using this product. Regular monitoring of liver function may be warranted in these patients to ensure safety and to mitigate the risk of hepatotoxicity.

Overdosage

In cases of overdosage, severe liver damage may occur if an individual ingests more than 10 Softgels within a 24-hour period, which is the maximum recommended daily dosage for this product.

Healthcare professionals should be vigilant for symptoms indicative of liver impairment, which may include jaundice, abdominal pain, nausea, vomiting, and confusion.

Management of overdosage should involve immediate medical evaluation. It is crucial to assess liver function and initiate appropriate supportive care. In cases of suspected overdose, contacting a poison control center or seeking emergency medical assistance is recommended to ensure timely intervention and monitoring of the patient's condition.

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 several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this medication 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 check with their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be advised to stop use and consult a doctor if new symptoms arise or if a cough returns, particularly if accompanied by a rash or a headache that lasts.

When using this product, patients must 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, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be instructed to consult 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 a temperature range of 20-25°C (68-77°F). Care should be taken to avoid high humidity and excessive heat during storage. Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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