Dg Health Multi Symptom Severe Cold

Description

Acetaminophen is a pain reliever and fever reducer, while dextromethorphan HBr serves as a cough suppressant. Phenylephrine HCl functions as a nasal decongestant. The formulation is presented in a convenient packet format, with each packet containing a blend of green tea and honey lemon flavors. This product is available in a pack of six packets.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold. Specifically, it alleviates minor aches and pains, minor sore throat pain, headache, nasal and sinus congestion, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The standard dosing regimen for adults and children aged 12 years and older is one packet every four hours, as needed, while symptoms persist. It is imperative not to exceed six packets within a 24-hour period unless otherwise directed by a healthcare professional.

For administration, the contents of one packet should be dissolved in 8 ounces of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If a microwave is used for preparation, the contents of one packet should be added to 8 ounces of cool water. The mixture must be stirred briskly both before and after heating to ensure proper dissolution. Care should be taken not to overheat the solution.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 12 years of age.

• In individuals with a history of allergic reactions to this product or any of its ingredients.

• Concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription medication, consultation with a doctor or pharmacist is recommended.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they 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.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, 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 physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, or emphysema. Additionally, those on a sodium-restricted diet should seek medical advice before use. It is also important to consult a doctor or pharmacist if the patient is taking warfarin, a blood-thinning medication.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if pain, cough, or nasal congestion worsens or persists beyond seven days. A return of cough accompanied by rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using the 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 consult a healthcare provider 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 advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Those with a cough that produces excessive phlegm or a chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice. Patients on a sodium-restricted diet should inquire with their doctor prior to use.

It is important for patients taking the blood-thinning medication warfarin to consult a doctor or pharmacist before using this product.

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

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication, due to the potential for increased bleeding risk.

Co-administration with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients are advised to verify the presence of acetaminophen in any other medications they may be taking by consulting a healthcare professional.

This product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it is important to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Patients uncertain about the presence of an MAOI in their current medications should seek guidance from a healthcare professional before use.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Multi Symptom Severe Cold (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For those aged 12 years and older, the recommended dosage is one packet. There are no established safety or efficacy profiles for children under 12, and use in this population is contraindicated.

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. 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 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

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 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, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers monitor the patient closely and initiate appropriate supportive care as needed.

In cases of suspected overdose, the following steps should be taken:

1. Assessment: Evaluate the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include airway management, intravenous fluids, and monitoring of cardiac function.

3. Decontamination: If the overdose is recent, consider gastrointestinal decontamination methods, such as activated charcoal, if appropriate and within the recommended time frame.

Healthcare professionals are encouraged to remain vigilant and act swiftly to ensure the safety and well-being of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

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 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 critical for both adults and children, even if no signs or symptoms are present.

Patients should be informed that this product is not recommended for use in children under 12 years of age. Additionally, they should be cautioned against using the product if they have a history of allergic reactions to it or any of its ingredients.

It is essential to instruct patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should also be made aware that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If patients are unsure whether their prescription includes an MAOI, they should be advised to seek clarification from a healthcare professional.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop use and seek medical advice if fever worsens or persists for more than three days, if redness or swelling occurs, or if new symptoms develop. Furthermore, patients should be informed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than seven days, or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should 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 that produces excessive phlegm or that is chronic, such as those associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Additionally, patients on a sodium-restricted diet or those 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 upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

Patients should take the medication every 4 hours while symptoms persist, ensuring not to exceed 6 packets in a 24-hour period unless directed by a healthcare professional. The contents of one packet should be dissolved in 8 oz. of hot water and sipped while hot, with the entire drink consumed within 10-15 minutes. If using a microwave, the packet's contents can be added to 8 oz. of cool water, stirred briskly before and after heating, and care should be taken to avoid overheating.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)