Phenylephrine hydrochloride/Acetaminophen/Guaifenesin/Dextromethorphan hydrob...

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with the common cold and flu. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

The drug provides temporary relief from the following symptoms due to a cold or flu:

• Nasal congestion

• Sinus congestion and pressure

• Minor aches and pains

• Headache

• Cough

• Sore throat

• Fever

Limitations of use have not been specified in the provided information.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 capsules with water every 4 hours as needed. The total daily dosage must not exceed 12 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age. It is imperative that patients adhere to the recommended dosing guidelines and avoid exceeding the specified dosage.

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 interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

• Use in children under 12 years of age is contraindicated due to safety concerns.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

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

It is imperative to keep this product out of reach of children. In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or persists beyond three days; the presence of redness or swelling; the emergence of new symptoms; or if a cough recurs alongside fever, rash, or headache. These symptoms may indicate a serious underlying condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

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 4,000 mg of acetaminophen in 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 or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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, as these may warrant prompt medical consultation.

It is recommended that patients stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer 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 fever, rash, or headache that persists. These symptoms could indicate a serious condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement should consult a doctor before using this product. Those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those experiencing a cough with excessive phlegm, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. This is essential to ensure safe and effective use, as potential interactions may affect the efficacy of warfarin and increase the risk of bleeding.

Currently, there are no additional drug interactions or laboratory test interactions reported for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are available beyond the advice to consult a healthcare provider when using this medication in conjunction with warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Severe Cough Mucus and Congestion. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 capsules taken with water every 4 hours, with a maximum of 12 capsules in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 drug 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 available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an increased risk of severe liver damage while using this product. Therefore, it is advisable for patients with compromised liver function to consult with a healthcare professional regarding their alcohol consumption and to consider potential dosage adjustments or alternative therapies. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. It is critical to avoid the concurrent use of any other medications that contain acetaminophen, as this can significantly increase the risk of overdose.

If an overdose is suspected, it is imperative to seek emergency medical assistance immediately. Prompt intervention is essential to mitigate potential harm and manage the consequences of acetaminophen overdosage effectively.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has revealed reports of severe allergic reactions associated with the use of acetaminophen. These reactions include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. Additionally, there have been reports of liver damage in patients who have exceeded the recommended dosage of acetaminophen or who have used it in conjunction with other products containing acetaminophen.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or 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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is essential to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, this product is not recommended for children under 12 years of age.

Patients should be instructed to stop using the product and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than 7 days, or if their fever worsens or lasts more than 3 days. They should also seek medical advice if they notice any redness or swelling, experience new symptoms, or if their cough returns or occurs with fever, rash, or a headache that lasts, as these may indicate a serious condition. Furthermore, patients should be advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

When using this product, patients must not 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 persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before use. Additionally, patients with a cough that produces excessive phlegm (mucus) should consult a healthcare provider prior to using this product. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before using this product.

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 15-25ºC (59-77ºF) 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

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Severe Cough Mucus and Congestion, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)