Cold and Flu Relief

Description

This formulation is designed for daytime cold and flu relief, containing the following 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 addresses symptoms such as aches, fever, sore throat, cough, and nasal congestion. The product is suitable for individuals aged 6 years and older, is alcohol-free, antihistamine-free, and formulated to be non-drowsy. It is available in an original flavor and is presented in a tamper-evident container, with a warning to not use if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072. It is important to note that this product is not manufactured or distributed by The Procter & Gamble Company, and Vicks® and DayQuil® 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, fever, nasal congestion, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is important to consult a physician for children aged 4 to under 6 years, as specific dosing instructions should be obtained. The product is not recommended for use in children under 4 years of age.

Healthcare professionals should emphasize that no more than 4 doses should be administered within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not recommended. It is essential to keep the dosing cup with the product to ensure accurate measurement.

When utilizing both Day Time and Night Time formulations, healthcare providers should instruct patients to carefully read each label to confirm the correct dosing for each product.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, due to the risk of serious interactions. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their medication.

• Co-administration with any other drug containing acetaminophen, as this may lead to an increased risk of acetaminophen-related toxicity. Patients should verify the contents of their medications with a healthcare professional if unsure.

• Exceeding the recommended dosage is contraindicated, as it may result in liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

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 adhere strictly to the following dosing recommendations to mitigate this risk:

• Adults should not exceed 4 doses (30 mL each) within a 24-hour period, which constitutes the maximum daily amount.

• Children should not take more than 4 doses (15 mL each) in a 24-hour period.

• Patients must avoid concurrent use with other medications containing acetaminophen.

• Adults consuming 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients are advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider promptly.

Overdose Warning Exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should be advised to stop using the product and consult a healthcare professional if any of the following occur:

• Redness or swelling at the site of use

• The emergence of new symptoms

• Symptoms such as nervousness, dizziness, or sleeplessness

• Worsening fever or fever lasting more than 3 days

• Pain, nasal congestion, or cough that worsens or persists beyond 5 days in children or 7 days in adults

• Recurrence of cough accompanied by rash or headache lasting longer than expected

These symptoms may indicate a serious underlying condition that requires further evaluation. Regular monitoring and appropriate laboratory tests may be warranted based on the clinical scenario and patient history.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Adults should not take more than 4 doses (30 mL each) in a 24-hour period, while children should not exceed 4 doses (15 mL each) within the same timeframe. The risk of liver damage is further increased if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this 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.

A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider. Additionally, patients should stop use and consult a doctor if they experience redness or swelling, new symptoms, nervousness, dizziness, sleeplessness, or if fever worsens or lasts more than 3 days. For children, if pain, nasal congestion, or cough worsens or lasts more than 5 days, or for adults if these symptoms persist for more than 7 days, medical advice should be sought. A cough that recurs or occurs alongside a rash or headache that lasts may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those on a sodium-restricted diet should consult a doctor before using this product. Additionally, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or those experiencing cough with excessive phlegm should seek medical advice prior to use. It is also recommended that patients taking the blood-thinning medication warfarin consult a healthcare professional before using acetaminophen.

Overdose of acetaminophen can lead to significant liver damage. In cases of 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 product with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on a prescription MAOI or for a period of two weeks following the discontinuation of the MAOI. It is essential for patients to consult with a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Additionally, caution is advised when this product is used in conjunction with warfarin, a blood-thinning medication. Patients should seek guidance from a healthcare provider or pharmacist prior to using this product if they are currently taking warfarin, to ensure safe and effective use.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning associated with this medication; pediatric patients should not exceed 4 doses of 15 mL within a 24-hour period. Additionally, if a child's pain, nasal congestion, or cough worsens or persists beyond 5 days, it is important to discontinue use and consult a doctor.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or are on a sodium-restricted diet. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant medication warfarin, as potential interactions may necessitate careful monitoring.

It is important to note that exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is crucial for elderly patients, as well as for children, even in the absence of noticeable signs or symptoms.

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 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 closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the following dosing guidelines are exceeded: adults should not take more than 4 doses (30 mL each) in a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can significantly increase the risk of liver damage.

Patients with a history of liver disease should consult a healthcare professional before using this product. Furthermore, adults consuming three or more alcoholic drinks daily while using this product are at an increased risk for liver damage and should seek medical advice prior to use.

In the event of an overdose, which may lead to liver damage, immediate medical assistance is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms of overdose are apparent. Quick medical attention is vital for both adults and children in such situations.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of prompt evaluation and management, even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary steps to take in the event of an overdose.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, as exceeding this dosage may lead to liver damage. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience any of the following: redness or swelling, the emergence of new symptoms, feelings of nervousness, dizziness, or sleeplessness, a worsening fever that lasts more than three days, or if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. Additionally, patients should seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts.

It is essential for patients to consult a healthcare provider before using this medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a sodium-restricted diet, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), a cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

Patients should also be advised to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin.

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 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

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)