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, 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

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours as needed. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. It is advised to consult a physician for children aged 4 to under 6 years, and the product should not be used in children under 4 years of age.

Healthcare professionals should emphasize that patients must not exceed the directed dosage, which includes a maximum of 4 doses within any 24-hour period. It is crucial to measure the dosage using the dosing cup provided with the product; no other dosing devices should be utilized to ensure accurate measurement. The dosing cup should be kept with the product for convenience.

When patients are using other Daytime or Nighttime products, they should be instructed to carefully read each label to confirm correct dosing and avoid potential overdose.

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, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

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 if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blistering, or rash. In the event of any skin reaction, 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 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. Additionally, patients with a persistent or chronic cough, such as those with smoking, asthma, or emphysema, should seek medical advice before use. It is also recommended that patients taking the anticoagulant warfarin consult with a healthcare provider or pharmacist prior to using this product.

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 without delay, 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 fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting beyond a reasonable duration may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Adults should not take more than 4 doses (30 mL each) in 24 hours, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the 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.

Participants should consult a healthcare provider if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Patients are advised to stop use and seek medical advice 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 fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious condition.

It is recommended that patients consult a healthcare professional prior to use 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 or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

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 present.

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 hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 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 healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

Healthcare providers should be aware of specific warnings regarding the treatment of pediatric patients. If pain, nasal congestion, or cough worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Additionally, in the event of an overdose, prompt medical attention is critical for children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available 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. 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 on the excretion of this drug 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 adults do not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, as this represents the maximum daily amount. For children, the maximum is 4 doses (15 mL each) in a 24-hour period.

Additionally, patients should be aware that the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

Taking more than the recommended dose of this medication can lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately 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 are initially apparent.

Healthcare professionals should be aware that the potential for liver damage necessitates a high index of suspicion in cases of overdose. Monitoring and supportive care may be required, and specific management protocols should be followed based on the severity of the overdose and the clinical presentation of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may include skin reddening, blistering, 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 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, patients must 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 instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. If fever intensifies or lasts more than 3 days, or if any redness or swelling occurs, patients should also stop use and contact a healthcare professional.

It is important for patients to be aware that new symptoms may arise, and they should seek medical advice if these occur. They should also be informed to stop use and consult a doctor if a cough returns or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the 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, or a cough associated with excessive phlegm. Furthermore, patients with a persistent or chronic cough, such as that caused by smoking, asthma, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using 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 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)