Dg Health Cold and Flu Severe

Description

This product is a maximum strength formulation designed for the relief of cold and flu symptoms. It contains a combination of active ingredients including acetaminophen, phenylephrine HCl, dextromethorphan HBr, and doxylamine succinate. Acetaminophen serves as a pain reliever and fever reducer, while phenylephrine HCl acts as a nasal decongestant. Dextromethorphan HBr functions as a cough suppressant, and doxylamine succinate provides antihistamine properties. The product is intended for nighttime relief and is available in a honey flavor. It is packaged in a 12 FL OZ (355 mL) bottle.

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, cough to facilitate sleep, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing. Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. 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 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 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.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of overdose.

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 drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• Use in children for the purpose of inducing sleep is contraindicated.

• History of allergic reactions to this product or any of its ingredients precludes its use.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period, while children should not take more than 5 doses in the same timeframe. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, glaucoma, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or any breathing problems such as emphysema or chronic bronchitis. Additionally, individuals with persistent or chronic coughs, such as those caused by smoking, asthma, or emphysema, should also consult a healthcare provider.

Patients should inform their doctor or pharmacist if they are currently taking blood thinners, such as warfarin, or if they are using sedatives or tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, regardless of the presence of symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with the use of acetaminophen include the potential for severe liver damage, particularly if an adult exceeds 4,000 mg in a 24-hour period, a child takes more than 5 doses in 24 hours, the product is used in conjunction with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if a patient experiences a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, glaucoma, thyroid disease, diabetes, high blood pressure, or urinary issues due to an enlarged prostate should seek medical advice before using this product. Additionally, those experiencing a cough with excessive phlegm or with a history of breathing problems, such as emphysema or chronic bronchitis, should also consult a healthcare provider prior to use.

When using this product, it is crucial to adhere to the recommended dosage. Patients, particularly children, may experience excitability, and marked drowsiness may occur. Caution is advised when driving or operating machinery, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

The concomitant use of this product with certain medications may lead to significant interactions that require careful consideration.

Anticoagulants The use of this product alongside warfarin may elevate the risk of bleeding. It is advisable to monitor patients closely for any signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Sedatives and Tranquilizers Co-administration of this product with sedatives or tranquilizers can enhance drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery. Monitoring for excessive sedation is recommended.

Acetaminophen This product should not be used concurrently with any other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Monoamine Oxidase Inhibitors (MAOIs) Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOIs within the past two weeks should consult a healthcare professional prior to using this product. This precaution is essential to prevent potential adverse effects associated with the interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Cold and Flu Severe (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect. Parents and caregivers should monitor children for worsening symptoms; if pain, nasal congestion, or cough persists beyond 5 days, or if fever worsens or lasts more than 3 days, medical advice should be sought.

In the event of an overdose, immediate medical assistance is crucial. Caregivers should contact a Poison Control Center without delay, as prompt attention is essential for both children and adults, even if no symptoms are apparent.

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 adverse effects or changes in therapeutic response, 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 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 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on therapy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the risks and benefits of therapy in these patients.

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 prior to use.

Excitability has been observed, particularly in children, and marked drowsiness may also occur.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

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 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 signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such 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 should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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