Dg Health Cold Plus Flu Relief

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 cough due to minor throat and bronchial irritation, minor aches and pains, nasal congestion, sore throat, headache, 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 four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours as needed.

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

The medication is not indicated 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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, refrain from using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should be instructed to 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 advised to consult a healthcare provider promptly.

It is essential to instruct patients not to exceed the recommended dosage of this product.

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

Patients should also be advised to stop taking the product and consult a healthcare professional if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or lasts more than three days; any redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with the use of acetaminophen include the potential for severe liver damage, particularly if patients exceed 4,000 mg within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Additionally, patients experiencing a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting should consult a healthcare professional without delay.

Common adverse reactions warranting medical consultation include symptoms such as nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever intensifies or persists beyond three days, if redness or swelling occurs, or if new symptoms develop. Furthermore, a recurrence of cough, especially when accompanied by a rash or headache that lasts, may indicate a serious underlying condition and should be evaluated by a healthcare provider.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. The interaction between acetaminophen and warfarin may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of anticoagulation therapy.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Cold Plus Flu Relief (acetaminophen, dextromethorphan hydrobromide, 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 2 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

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. 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 evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for patients with reduced kidney function to ensure safety and efficacy.

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. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 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 immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients must be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that this product should not be used 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 verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be made aware that they should not use this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should also inform patients 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, patients should be advised to consult a doctor if their fever worsens or lasts longer than three days, or if they notice any redness or swelling. New symptoms that arise should prompt a discussion with a healthcare provider.

Patients should be cautioned that if their cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. It is important to emphasize that patients should adhere strictly to the recommended dosage and not exceed the directed amount.

Before using this product, patients should be encouraged to consult a healthcare provider if they have a cough accompanied by excessive phlegm, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they experience difficulty urinating due to an enlarged prostate gland. Additionally, patients with liver disease, heart disease, high blood pressure, thyroid disease, or diabetes should seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should consult with their 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 should be ensured to prevent exposure to extreme temperatures or environmental factors that may compromise the product's quality.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 4 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)