Ultra Concentrated Daytime Cold and Flu

Description

Ultra Concentrated Daytime COLD AND FLU Capsules are presented in a dosage form of softgels, with a total of 8 softgels per package. The product is identified by the National Drug Code (NDC) 51013-667-01. This formulation is designed to provide relief comparable to the active ingredients found in Vicks® DayQuil® Cold & Flu LiquiCaps®.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, cough, sore throat, and the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels with water every 4 hours as needed. The total daily dosage must not exceed 8 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere strictly to the recommended dosage to avoid potential adverse effects.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• In individuals with a known allergy to this product or any of its components, to prevent potential allergic reactions.

• In children under 12 years of age, due to safety concerns regarding efficacy and potential adverse effects.

Additionally, it is important to adhere to the recommended dosage to avoid complications.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 10 softgels in a 24-hour period. Patients should be cautioned against the concurrent use of other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash warrant immediate cessation of the product and prompt medical attention.

Healthcare providers should recommend that patients seek medical advice prior to using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult with a healthcare professional or pharmacist before use.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Timely intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience any of the following: worsening pain or cough lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache; or symptoms of nervousness, dizziness, or sleeplessness. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels 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 skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to consult a healthcare professional 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. Additionally, patients should stop use and seek medical advice if pain or cough worsens or lasts longer 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 with a rash or headache that persists. These symptoms may indicate a serious condition. Patients may also experience nervousness, dizziness, or sleeplessness, which warrant consultation with a healthcare provider.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent or chronic cough (such as that associated with smoking, asthma, or emphysema) should seek medical advice.

Furthermore, individuals taking the blood-thinning medication warfarin are advised to consult a doctor or pharmacist prior to use.

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) for the treatment of depression, psychiatric disorders, 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 and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult with 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 Ultra Concentrated Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For children 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, unless otherwise directed by a healthcare professional.

Healthcare providers should advise parents or guardians to consult a doctor before administering this medication if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical attention is necessary, and contacting a Poison Control Center is advised. Quick medical attention is critical for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum recommended dosage is 10 softgels within a 24-hour period; exceeding this limit may result in severe liver damage.

Additionally, the risk of severe liver damage is heightened if this product is taken concurrently with other medications containing acetaminophen. Patients are also advised that consuming three or more alcoholic drinks daily while using this product may lead to severe liver damage.

It is imperative that patients with liver disease consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is essential for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals are advised to remain vigilant, as the lack of immediate symptoms does not preclude the possibility of serious health consequences. Therefore, timely evaluation and management are crucial to mitigate potential risks associated with 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 use of the compound in these contexts.

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 product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be instructed not to exceed the recommended dosage while using this product. It is important for healthcare providers to 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, a cough with excessive phlegm (mucus), difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Additionally, patients should be advised to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin, as this may require special consideration.

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, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children 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 unless otherwise directed by a healthcare professional. Use is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, 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 Ultra Concentrated Daytime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)