Cold and Flu Relief

Description

This formulation contains Acetaminophen 325 mg, a pain reliever and fever reducer, Dextromethorphan HBr 10 mg, a cough suppressant, and Phenylephrine HCl 5 mg, which addresses nasal congestion. The product is alcohol-free and does not contain antihistamines.

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 physician for children aged 4 to under 6 years regarding appropriate dosing. 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; no other dosing devices should be utilized. 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 confirm correct dosing.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the following conditions are met: adults taking more than 4 doses (30 mL each) of acetaminophen within a 24-hour period, children taking more than 4 doses (15 mL each) in the same timeframe, concurrent use with other medications containing acetaminophen, or adults consuming 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blistering, or rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly.

General Precautions Prior to use, patients should be advised to consult a healthcare professional 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, or a cough associated with excessive phlegm (mucus). Additionally, those with a persistent or chronic cough, such as that seen in smoking, asthma, or emphysema, should seek medical advice. It is also recommended that patients consult a doctor or pharmacist if they are taking the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Patients should stop taking the product 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 warranted. 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 or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 4 doses (30 mL each) in 24 hours for adults or 4 doses (15 mL each) for children. The risk of liver damage is further increased if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the patient 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue 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 lasts more than 3 days; if redness or swelling is present; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to use, patients should seek medical advice 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 or chronic conditions such as smoking, asthma, or emphysema. Additionally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before use.

An overdose warning is in place, as taking more than the recommended dose 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 apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

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

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 mothers.

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 in the absence of noticeable signs or symptoms.

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, not only for adults but also for children, even in the absence of noticeable signs or symptoms of overdose.

Prompt intervention can significantly mitigate the risks associated with overdose and improve patient outcomes. Therefore, it is essential to educate patients and caregivers about the importance of adhering to prescribed dosages and recognizing the urgency of seeking help 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 that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blistering, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if the following occur: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; the emergence of new symptoms; fever that worsens or persists beyond 3 days; presence of redness or swelling; or a cough that recurs or is accompanied by a rash or headache lasting longer than usual. These symptoms may indicate a serious condition.

Furthermore, an overdose warning is emphasized, as exceeding the recommended dosage can lead to serious 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 in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to serious liver damage. In the event of an overdose, patients should seek medical help 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 informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to caution patients against using 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 includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. New symptoms, worsening fever lasting more than 3 days, or the presence of redness or swelling should also prompt a consultation with a healthcare provider. Patients should be made aware that a returning cough, especially if accompanied by a rash or persistent headache, may indicate a serious condition and warrants immediate medical attention.

While 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, a sodium-restricted diet, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, or emphysema should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in specific packaging configurations, with relevant NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product 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)