Cold and Flu Relief

Description

Acetaminophen, dextromethorphan HBr, and phenylephrine HCl are the active ingredients in this formulation, which serves as a multi-symptom relief medication. It is indicated for the alleviation of headache, fever, sore throat, minor aches and pains, nasal congestion, and cough. The product is alcohol-free and antihistamine-free, providing a comprehensive approach to symptom management.

The formulation is designed to be tamper evident, with a safety seal present around the dosage cup and under the cap. It is distributed by GoBrands, Inc., located in Philadelphia, PA 19123.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, fever, sore throat, 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 as needed. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is important to consult a healthcare professional 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.

Patients should not exceed 4 doses within a 24-hour period. It is essential to measure the dosage using only the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to ensure proper measurement.

When using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure correct dosing and avoid potential overdosing.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Additionally, it is important not to exceed the recommended dosage 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 that adults must not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, while children should not take more than 4 doses (15 mL each) in the same timeframe. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blistering, or rash. Should any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

General precautions should be taken for patients with specific health conditions. Prior to use, individuals should consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a sodium-restricted diet, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with persistent or chronic coughs, such as those caused by smoking, asthma, or emphysema, should also seek medical advice before using this product. Furthermore, it is essential to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, even if no signs or symptoms are apparent.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if new symptoms arise, medical consultation is necessary. Patients should also seek medical advice if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition.

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) in 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, blistering, 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.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults; if new symptoms arise; if fever worsens or persists for more than 3 days; if redness or swelling is observed; or if a cough recurs or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Prior to using acetaminophen, patients should consult a healthcare professional if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a sodium-restricted diet, difficulty urinating due to an enlarged prostate gland, or a persistent cough associated with excessive phlegm, smoking, asthma, or emphysema. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use.

An overdose of acetaminophen can lead to serious 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 present.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

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 a liver warning indicating that if a child takes more than 4 doses (15 mL each) within a 24-hour period, medical advice should be sought. Additionally, if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days, it is important to stop use and consult a doctor.

In cases of suspected overdose, quick medical attention is critical for pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects, which should be considered when prescribing this medication. Although no specific information is provided regarding dosage adjustments or safety concerns for geriatric patients, caution is advised.

Healthcare providers should inquire about the presence of comorbid conditions that are more prevalent in elderly patients, such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a sodium-restricted diet, or urinary difficulties due to an enlarged prostate gland. It is recommended that elderly patients consult their healthcare provider before initiating treatment, particularly if they have any of these underlying health issues.

Close monitoring of elderly patients is advisable to ensure safety and efficacy during treatment.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the following maximum daily doses: adults should not take more than 4 doses (30 mL each) of acetaminophen 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 further increase the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, adults consuming 3 or more alcoholic drinks daily while using this product should also seek medical advice, as this may exacerbate the risk of liver damage.

In the event of an overdose, which can lead to serious liver damage, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Overdosage

Taking more than the recommended dose of this medication can 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 medical attention is crucial for both adults and children, even in instances where no signs or symptoms are immediately apparent. Early intervention can significantly impact the outcome and mitigate the risk of severe complications associated with 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blistering, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage, as taking more than the prescribed amount can lead to serious liver damage. In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be encouraged to consult with their 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, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema.

Additionally, it is important for patients to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking the blood-thinning medication warfarin, to ensure safe and effective use of 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 temperature range of 20º-25ºC (68º-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)