Drx Choice Maximum Strength Severe

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement, and it should be kept with the product at all times to ensure proper dosing. This formulation is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, and for 2 weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. Specifically, patients must not exceed 6 doses within a 24-hour period, which constitutes the maximum daily amount. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming 3 or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance without delay.

Healthcare professionals should also be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, as timely intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: worsening pain or cough lasting more than 7 days; fever that worsens or persists for more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting beyond a short duration. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount. The risk is further heightened if the product is taken in conjunction with other medications containing acetaminophen or if patients consume 3 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.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Other adverse reactions warranting attention include worsening pain or cough lasting more than 7 days, fever that worsens or lasts more than 3 days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs alongside a rash or headache lasting for an extended period. These symptoms may indicate a serious condition, and patients should seek medical advice if they experience any of these issues.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

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

Packaging & NDC

Below are the non-prescription pack sizes of Drx Choice Maximum Strength Severe (acetaminophen, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For individuals aged 12 years and older, the recommended dosage is 20 mL every 4 hours. Caution is advised when considering the use of this product in children under 12 years.

Geriatric Use

Elderly patients should be aware that this adult product is not intended for use in individuals under 12 years of age. It is crucial for geriatric patients to consult a healthcare provider prior to use if they have a history of liver disease, as this may impact the safety and efficacy of the product.

Additionally, elderly patients who are currently taking the blood-thinning medication warfarin or any other pain reliever or fever reducer should seek advice from a doctor or pharmacist before using this product. This precaution is important to avoid potential drug interactions that could lead to adverse effects.

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 patients should be particularly vigilant regarding this warning, as they may be at increased risk for complications.

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 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily amount of 6 doses within any 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product. Due to the potential for increased susceptibility to liver damage, careful consideration of the patient's overall liver function and alcohol intake is essential in managing their treatment. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with any medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances. The clinical presentation can vary significantly depending on the substance involved and the individual patient's response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare professionals should ensure that the patient is stabilized, which may include maintaining airway patency, providing oxygen, and monitoring vital signs. In cases where a specific antidote is available, it should be administered as per established protocols.

It is crucial to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the specific circumstances and the substance involved. Documentation of the incident and any interventions performed is also important for ongoing patient care and safety monitoring.

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 the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance promptly.

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. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medication that contains acetaminophen, whether prescription or nonprescription. Patients should be advised to verify the contents of their medications with a healthcare professional if they are unsure.

Patients should be counseled to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days. Additionally, they should seek medical advice if their fever worsens or lasts longer than three days, if they notice any redness or swelling, or if new symptoms arise. They should also be informed to stop use and consult a doctor if their cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have liver disease, a cough accompanied by excessive phlegm, or any breathing problems, including chronic coughs associated with smoking, asthma, or emphysema. Furthermore, patients should be advised to speak with their doctor or pharmacist if they are taking the blood-thinning medication warfarin or any other pain reliever or fever reducer.

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 room temperature, ensuring that it is not refrigerated. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Drx Choice Maximum Strength Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)