Dg Health Cold and Flu Relief

Description

Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate are the active ingredients in this formulation, which serves as a multi-symptom relief medication. It is indicated for the alleviation of aches, fever, sore throat, sneezing, runny nose, and cough. The product is presented in the form of softgels, with a total of 24 softgels per package. Each softgel is designed to provide effective pain relief, fever reduction, cough suppression, and antihistamine action.

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, runny nose, sneezing, 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 six 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 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 guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, 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 advised to consult a healthcare provider promptly.

General precautions should be taken when considering the use of this product. Patients should be instructed to consult a physician prior to use if they have a cough that produces excessive phlegm, a history of breathing problems such as emphysema or chronic bronchitis, liver disease, glaucoma, a persistent or chronic cough (as seen in smoking, asthma, or emphysema), or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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, regardless of whether symptoms are present, as prompt intervention is essential for both adults and children.

Patients must be advised to discontinue use and contact a healthcare provider if any of the following occur: worsening pain or cough lasting more than seven days, the presence of redness or swelling, a fever that worsens or lasts more than three days, the emergence of new symptoms, or a recurrence of cough 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 liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, 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.

Participants should also be 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.

Patients are instructed to stop use and contact a doctor if pain or cough worsens or lasts longer than seven days, if redness or swelling is observed, if fever worsens or lasts more than three days, if new symptoms arise, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition.

While using this product, patients may experience excitability, particularly in children. Caution is advised when driving a motor vehicle or operating machinery, as marked drowsiness may occur. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and it is recommended to avoid alcoholic beverages during treatment.

Drug Interactions

Co-administration of this product with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and associated hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should consult a healthcare professional before using this product. This consultation is also advised for individuals who have discontinued MAOI therapy within the past two weeks, as interactions may occur.

The concomitant use of sedatives or tranquilizers with this product may enhance drowsiness. Therefore, caution is advised when engaging in activities that require alertness, such as driving or operating machinery.

Additionally, the use of this product alongside the anticoagulant warfarin may lead to potential interactions, necessitating careful monitoring of coagulation parameters to ensure patient safety.

Alcohol consumption, as well as the use of sedatives and tranquilizers, may further increase drowsiness when taken with this product. It is recommended that patients limit or avoid these substances to mitigate the risk of excessive sedation.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate). 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 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 potential 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if the total daily dose of acetaminophen exceeds 4,000 mg. Additionally, patients must avoid concomitant use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Patients with compromised liver function are advised to limit alcohol consumption, as the risk of severe liver damage increases significantly with the intake of three or more alcoholic drinks per day while using this product.

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 prevent potential adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, the consumption of three or more alcoholic beverages daily while using acetaminophen can exacerbate the risk of severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are essential components of management.

Prompt recognition and intervention are critical to mitigate the potential consequences of acetaminophen overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of acetaminophen, reported voluntarily or through surveillance programs.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been noted. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately. Additionally, excitability has been reported, particularly in pediatric populations.

The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, with marked drowsiness being a potential outcome. Reports indicate that pain or cough may worsen or persist beyond 7 days, and the presence of redness or swelling should be monitored. Furthermore, worsening fever lasting more than 3 days and the emergence of new symptoms have been documented.

Cough that recurs or occurs alongside a rash or headache that persists may indicate a serious condition requiring medical evaluation. In cases of overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt attention is crucial for both adults and children, even if no 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 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 one within the last two weeks. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. They should also be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists beyond seven days, if they experience redness or swelling, if their fever intensifies or lasts more than three days, or if new symptoms arise. Additionally, patients should seek medical advice if their cough returns or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children. They should exercise caution when driving or operating machinery, and it is advisable to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should be informed that marked drowsiness may occur.

Healthcare providers should recommend that patients consult a doctor before using this product if they have a cough associated with excessive phlegm, a breathing problem such as emphysema or chronic bronchitis, liver disease, glaucoma, a persistent or chronic cough related to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to speak with a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to 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 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor, while the use of this 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. Patients are also advised to exercise caution when driving or operating machinery, as the medication may cause drowsiness, which can be exacerbated by alcohol, sedatives, and tranquilizers. It is recommended to avoid alcoholic beverages while using this medication.

Drug Information (PDF)

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

View product document (PDF)