Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, headache, sore throat, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

The drug provides symptomatic relief for cough, sneezing, runny nose, headache, fever, sore throat, and minor aches and pains.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the prescribed dosage is 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. It is imperative that patients do not exceed the directed dosage, as outlined in the Overdose warning.

For accurate measurement, the dosing cup provided with the product must be used exclusively; other dosing devices are not acceptable. The dosing cup should be kept with the product to ensure proper administration.

Children under 12 years of age should not use this product. When utilizing other Day Time or Night Time formulations, it is essential to carefully read each label to confirm appropriate dosing and avoid potential overdosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare provider if any of the following occur: worsening pain or cough lasting more than seven days, the emergence of new symptoms, fever that worsens or persists beyond three 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 underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to stop use and seek medical help immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, if redness or swelling is present, or if a cough recurs with a rash or headache that persists. These symptoms could indicate a serious condition requiring medical evaluation.

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 (acetaminophen, dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. When administered, excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, it is crucial to seek medical assistance 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. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 difficulties with urination 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 be closely monitored due to the potential for severe liver damage associated with this product, which contains acetaminophen. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Contacting a Poison Control Center (1-800-222-1222) is essential, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

In cases of overdose, it is imperative to recognize the potential for serious health consequences, particularly concerning liver damage. Healthcare professionals should be aware that exceeding the recommended dosage can lead to significant adverse effects.

Recommended Actions In the event of an overdose, immediate medical assistance is crucial. Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, even in the absence of noticeable symptoms.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of prompt evaluation and intervention. Healthcare professionals should remain vigilant and consider the possibility of overdose in patients presenting with unexplained symptoms.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. Early intervention can significantly improve outcomes and mitigate the risk of severe complications.

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

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to 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 signs or symptoms are apparent.

When using this product, patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is important to counsel patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Additionally, patients should exercise caution when driving or operating machinery due to the potential for impaired alertness.

Patients should be instructed to stop using the product and consult a doctor if their pain or cough worsens or persists for more than 7 days, if new symptoms arise, if fever worsens or lasts more than 3 days, if redness or swelling is observed, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition that requires medical evaluation.

Healthcare providers should also recommend that patients consult a doctor before using this product if they have a history of liver disease, glaucoma, a cough accompanied by excessive phlegm, breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema, or difficulties urinating due to an enlarged prostate gland.

Furthermore, patients should be advised to speak with their doctor or pharmacist prior to use if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with the 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 product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. An overdose may lead to liver damage; therefore, patients should seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if an overdose occurs, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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