Dg Health Day Time Severe Cold and Flu Relief

Description

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, and Guaifenesin are the active ingredients in this formulation, which serves multiple therapeutic purposes including pain relief, fever reduction, nasal decongestion, cough suppression, and expectoration. The product is presented in the form of 12 caplets, designed to be non-drowsy. The caplets are formulated with Vapor Ice™ technology, contributing to their unique characteristics. The actual size of the caplet is consistent with standard dosage forms.

Uses and Indications

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

Additionally, this drug promotes freer breathing through the nose, facilitates nasal and/or sinus drainage, and aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs and assisting in the clearance of bothersome mucus from the bronchial passageways.

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 dosage should not exceed 8 caplets within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

This medication is not intended for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while taking this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

General precautions should be taken for patients with pre-existing conditions. Healthcare providers should recommend that patients consult a doctor prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a cough associated with excessive phlegm. Additionally, patients with a persistent or chronic cough, such as those with smoking-related conditions, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. It is essential to inquire about the concurrent use of warfarin, a blood-thinning medication, as it may interact with acetaminophen.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are apparent.

Patients should be advised to discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever persisting beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache warrant immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, 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.

A sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor 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 occurs; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to use, patients should consult a healthcare professional if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Patients should exercise caution when using this product in conjunction with certain medications due to potential drug interactions.

Anticoagulants Co-administration with warfarin, a blood-thinning agent, may necessitate careful monitoring. Patients are advised to consult a healthcare professional prior to use if they are currently taking warfarin to assess the risk of increased bleeding.

Monoamine Oxidase Inhibitors (MAOIs) The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it is advised that this product not be used for at least 2 weeks following the discontinuation of an MAOI. Patients uncertain about their medication's MAOI content should seek guidance from a healthcare provider before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Day Time Severe Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, 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 prior to use. The product is not recommended for children under 4 years of age.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics 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 safe 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure safe and effective use of the medication in individuals with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease 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. 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 at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there have been reports of new symptoms emerging, as well as instances where a cough recurs or occurs alongside a rash or persistent headache. These symptoms may indicate the presence of a serious condition, warranting further evaluation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial 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 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 stopped taking an MAOI within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should 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. Additionally, they should be instructed to contact a healthcare professional if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Patients should also be made aware that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

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 with a cough accompanied by excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised 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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dg Health Day Time Severe Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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