Cold and Flu Relief

Description

No description information is available for the specified drug.

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, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours.

For children aged 4 to under 6 years, it is advised to consult a physician before administration. The product is not recommended for use in children under 4 years of age.

It is important to note that no more than 4 doses should be taken 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. The dosing cup should be kept with the product for convenience.

When utilizing either the Daytime or Nighttime formulations, healthcare professionals should ensure that the correct dosing is followed by carefully reading each label.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to acetaminophen.

• Concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription. If uncertain about the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. It is recommended to verify the presence of an MAOI in any prescription medication with a healthcare professional prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients that the maximum daily dosage for adults is 4 doses (30 mL each) within a 24-hour period, and for children, it is 4 doses (15 mL each) in the same timeframe. Caution is particularly warranted if the patient is taking other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should 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 promptly.

General precautions should be taken for patients with specific health conditions. Healthcare professionals should recommend that patients consult a doctor before using this product if they have liver disease, respiratory issues such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, a persistent or chronic cough (especially associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

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, regardless of whether symptoms are present.

Patients should also be advised to stop using the product and consult a doctor if pain or cough worsens or lasts longer than 5 days for children or 7 days for adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. For adults, this risk is heightened if more than 4 doses (30 mL each) are taken within a 24-hour period, or if acetaminophen is used concurrently with other medications containing the same active ingredient. Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at increased risk. For children, exceeding 4 doses (15 mL each) in 24 hours poses a similar risk.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also in place; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms occur, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious condition.

It is contraindicated for individuals with a known allergy to acetaminophen to use this product. Patients should not use acetaminophen in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Prior to use, patients should consult a healthcare provider if they have liver disease, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm.

Patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using acetaminophen. An overdose warning is also issued; 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 apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Relief (acetaminophen dextromethorphan hbr). 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, with a maximum of 4 doses (15 mL each) in a 24-hour period. 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 instruct caregivers to discontinue use and seek medical advice if a child's pain or cough worsens or persists for more than 5 days, or if a fever worsens or lasts more than 3 days. An overdose warning is in place, emphasizing the necessity of prompt medical attention for children, even in the absence of noticeable signs or symptoms.

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 potential adverse effects or changes in efficacy, 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. 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 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 patient's specific condition.

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) 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 taking this product in conjunction with other medications containing acetaminophen, as this can increase the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume 3 or more alcoholic drinks daily should exercise caution, as concurrent use may exacerbate the risk of liver injury.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly liver damage, which may occur when the recommended dosage is exceeded. Healthcare professionals should be vigilant in assessing patients who may have ingested an excessive amount of the medication.

Immediate medical assistance is imperative. In cases of suspected overdose, it is recommended to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay. This is essential for both adults and children, as symptoms may not be immediately apparent.

Prompt intervention can significantly influence the outcome, making it vital to act quickly even in the absence of overt signs or symptoms of overdose. Healthcare providers should ensure that patients and caregivers are aware of these critical 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 these contexts.

Postmarketing Experience

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

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, known as an overdose, may lead to serious 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 no signs or symptoms of overdose are apparent.

Providers should reinforce the message that exceeding the recommended dosage can have severe consequences and should be strictly avoided.

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 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)