Dg Health Cold and Flu Relief

Description

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl are active ingredients in a formulation designed for multi-symptom relief, including pain relief, fever reduction, cough suppression, and nasal decongestion. This product is available in a dosage form of softgels, with a total of 32 softgels per package. The formulation provides relief from aches, fever, sore throat, nasal congestion, and cough, and is characterized as non-drowsy.

Additionally, a second formulation contains Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate, serving as a pain reliever, fever reducer, cough suppressant, and antihistamine. This variant is packaged with 16 softgels and offers multi-symptom relief from aches, fever, sore throat, sneezing, runny nose, and cough. Both formulations are presented in actual softgel size.

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, sore throat, headache, runny nose, sneezing, 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 healthcare professional for appropriate dosing guidance.

This medication is not recommended 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

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, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should also be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

In cases of suspected overdose, immediate medical attention is critical. Patients should be advised to contact a Poison Control Center at 1-800-222-1222, regardless of the presence of symptoms, as rapid intervention is essential for both adults and children.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition requiring further evaluation.

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 a dosage of 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.

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.

In cases of severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are also advised to stop use and contact a doctor if pain or cough worsens or persists for 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 returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, a persistent or chronic cough related to smoking, asthma, or emphysema, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should seek advice from a doctor or pharmacist before use if they are taking sedatives or tranquilizers, or the blood-thinning medication warfarin.

Drug Interactions

The concomitant use of this product with warfarin, an anticoagulant, may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. The potential for serious interactions necessitates careful patient assessment and alternative treatment options during this period.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate, 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 product is not recommended for children under 4 years of age.

For dosing, adults and children aged 12 years and older may take 2 softgels with water every 6 hours for nighttime cold and flu relief, and every 4 hours for daytime cold and flu relief.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific geriatric use information, dosage adjustments, or safety concerns outlined in the provided text. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may affect treatment outcomes. Regular monitoring and assessment of therapeutic response and adverse effects are recommended to ensure the safety and efficacy of the medication 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period, as this significantly increases the risk of liver injury.

Additionally, patients with compromised liver function should be advised against the concurrent use of other medications containing acetaminophen, as this can further elevate the risk of severe liver damage.

Patients are also cautioned regarding alcohol consumption; specifically, the intake of three or more alcoholic drinks per day while using this product may lead to severe liver damage. Therefore, it is recommended that patients with hepatic impairment limit or avoid alcohol consumption during treatment. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and mitigate the risk of hepatotoxicity.

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. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in individuals who consume three or more alcoholic beverages daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate hepatotoxicity, leading to potentially life-threatening conditions.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's clinical status and consider the need for supportive care and potential interventions, such as the administration of N-acetylcysteine, which may mitigate liver damage if given promptly. Monitoring liver function tests and providing symptomatic treatment are also critical components of management in cases of acetaminophen overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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 several adverse events reported voluntarily or through surveillance programs. Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Patients are advised to monitor for worsening pain or cough that persists beyond 7 days, as well as fever that lasts more than 3 days. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs alongside a rash or headache that persists may indicate a serious underlying condition, warranting further medical evaluation.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

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

Patients aged 12 years and older are advised to take 2 softgels of the Nighttime Cold & Flu formulation with water every 6 hours, while the Daytime Cold & Flu formulation should be taken at a frequency of 2 softgels every 4 hours.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the product 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 crucial for both adults and children, regardless of the presence of symptoms.

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.

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