Cold and Flu Relief

Description

This formulation contains three active ingredients: Acetaminophen 325 mg, a pain reliever and fever reducer; Dextromethorphan HBr 10 mg, a cough suppressant; and Phenylephrine HCl 5 mg, a nasal decongestant. It is indicated for the relief of aches, fever, sore throat, cough, and nasal congestion. The product is presented in a non-drowsy, alcohol-free, and antihistamine-free formulation, specifically as softgels (liquid-filled capsules).

The product features a tamper-evident design, with a warning stating: "DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." It is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087. This product is not manufactured or distributed by The Procter & Gamble Company, and Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, nasal congestion, fever, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. 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 two softgels taken with water every four hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

The use of this product is not recommended for children under 12 years of age. When utilizing both Daytime and Nighttime formulations, healthcare professionals should advise patients to carefully read each label to confirm the correct dosing instructions for each product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other medication containing acetaminophen, whether prescription or non-prescription, is 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 essential not to exceed the recommended dosage of this product to avoid potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 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 if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for individuals with specific health conditions. Patients should be advised to seek medical guidance before using this product if they have liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, those experiencing a cough with excessive phlegm should also consult a healthcare provider. It is essential to inquire with a doctor or pharmacist before use if the patient is taking the anticoagulant warfarin.

In cases of 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 right away, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare professional if they experience any of the following: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever that worsens or persists for more than three days; redness or swelling; the emergence of new symptoms; or a cough that recurs alongside a rash or headache lasting. 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 acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for signs of a severe sore throat, which may persist for more than two days or be accompanied by fever, headache, rash, nausea, or vomiting. In such cases, consulting a doctor promptly is recommended.

Patients are advised to stop use and consult a healthcare professional if they experience worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever that worsens or lasts more than three days; redness or swelling; new symptoms; or if a cough recurs with a rash or headache that persists. These symptoms could indicate a serious condition.

Furthermore, an overdose warning is in place, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking a prescription MAOI or for a period of two weeks following the discontinuation of an MAOI. This interaction may lead to serious adverse effects due to the potential for hypertensive crises or other severe reactions.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety and to adjust dosages as necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Relief (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 adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses in a 24-hour period. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information 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.

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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 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.

It is imperative that patients with liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that prompt medical intervention is essential for both adults and children, regardless of the presence of overt symptoms.

Recommended Actions In cases of suspected overdose, immediate medical assistance should be sought. It is advisable to contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be apparent, the risk of liver damage underscores the importance of vigilance and proactive management. Healthcare providers should monitor for any signs of hepatic distress and be prepared to initiate appropriate treatment protocols.

Management Procedures Upon confirmation of an overdose, healthcare professionals should follow established guidelines for the management of liver toxicity. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the clinical presentation of the patient.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of the medication. Patients must be informed that taking more than the recommended dose can lead to serious health risks, including potential liver damage.

In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if the patient does not exhibit any signs or symptoms of overdose.

Additionally, healthcare providers should reinforce the message that patients should not exceed the recommended dosage to avoid adverse effects and ensure their safety.

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 temperature range of 15-30ºC (59-86ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)