Alka-Seltzer Plus Day Severe Cold Plus Flu

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, including minor aches and pains, headache, sore throat, cough, nasal congestion, and sinus congestion and pressure. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. This drug also temporarily reduces fever.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is to dissolve the contents of one packet 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. Dosing may be repeated every 4 hours as needed, but the total intake must not exceed 6 packets within a 24-hour period unless directed by a healthcare professional.

It is important to note that this product is not intended for use in children under 12 years of age. Healthcare professionals should advise patients to adhere strictly to the recommended dosage and frequency to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions.

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

• In children under 12 years of age, due to safety concerns regarding efficacy and potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 packets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product. Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin. It is imperative that patients do not exceed the recommended dosage while using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever worsening or lasting more than 3 days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product if they exceed the maximum daily amount of 6 packets within 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are also cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients, as well as children under 12 years of age, should avoid its use.

Patients should seek medical advice before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Those taking the blood-thinning medication warfarin should also consult a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough returns or occurs with a rash or headache that persists. These symptoms may indicate a serious condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Day Severe Cold Plus Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is to dissolve the contents of one packet in 8 oz. of hot water and sip while hot, ensuring the entire drink is consumed within 10-15 minutes.

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Quick medical attention is critical for both adults and pediatric patients, even if no signs or symptoms are apparent.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 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 in urination due to enlargement of the 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 6 packets within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with their liver function. Monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

Nonclinical Toxicology

No data is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, including anaphylaxis, and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be instructed not to exceed the recommended dosage while using this product. It is important for healthcare providers to encourage patients to consult with a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with a cough that produces excessive phlegm (mucus) should also seek medical advice prior to use.

Furthermore, healthcare providers should remind patients to consult with a doctor or pharmacist before using this product if they are currently taking the blood-thinning medication warfarin, as interactions may occur.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours, not to exceed 6 packets within a 24-hour period unless directed by a healthcare professional. For adults and children aged 12 years and older, the contents of one packet should be dissolved in 8 oz. of hot water and consumed within 10-15 minutes while still hot. The use of this medication is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)