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 common cold and flu symptoms, including minor aches and pains, headache, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times to facilitate proper administration.

For children under 12 years of age, the product is not recommended for use. When patients are using other Day Time or Night Time products, they must carefully read each label to confirm the correct dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In 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 such treatment. The interaction between this product and MAOIs may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the 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 any skin reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than seven days; new symptoms develop; fever worsens or persists for more than three days; redness or swelling is observed; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should be cautious of the possibility of excitability, particularly in children, as well as marked drowsiness. It is advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery.

Patients are advised to stop use and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition.

In cases of overdose, which may result from exceeding the recommended dosage, patients may experience liver damage. Immediate medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. In such instances, patients should contact a Poison Control Center at 1-800-222-1222 without delay.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when co-administered with other medications containing acetaminophen or when consumed with three or more alcoholic beverages daily.

Dextromethorphan may enhance drowsiness when used concurrently with sedatives or tranquilizers, necessitating caution in patients who are prescribed these combinations.

Warfarin's anticoagulant effects may be modified by the concomitant use of acetaminophen. Therefore, it is recommended that the International Normalized Ratio (INR) be closely monitored in patients receiving both medications to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hydrobromide, 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. In children, the use of this medication may lead to excitability. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or modifications indicated for this population in the provided information. However, healthcare providers should remain vigilant in monitoring the overall health status of geriatric patients, considering their unique physiological changes and potential for polypharmacy. Regular assessment and individualized care are recommended to ensure optimal therapeutic outcomes in this demographic.

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 healthcare professional prior to using this medication. There is currently no available data on 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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The formulation contains acetaminophen, which poses a risk of severe liver damage if the daily dosage exceeds 4,000 mg. Additionally, the risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications that also contain acetaminophen.

Patients with compromised liver function are advised to avoid the consumption of three or more alcoholic drinks daily while using this product, as this may further increase the risk of severe liver damage.

In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. It is crucial to 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 of overdose.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly liver damage, associated with the ingestion of doses exceeding the recommended levels. Healthcare professionals should be vigilant in assessing patients who may have taken an overdose, as timely intervention is essential.

Recommended Actions In cases of suspected overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. It is important to act swiftly, as prompt medical attention can significantly impact patient outcomes.

Potential Symptoms Patients may not exhibit immediate signs or symptoms following an overdose; therefore, it is imperative to monitor both adults and children closely, even in the absence of overt clinical manifestations.

Management Procedures Upon presentation of an overdose case, healthcare professionals should conduct a thorough evaluation and initiate appropriate management protocols. This may include supportive care and specific interventions as guided by clinical protocols and the advice of poison control specialists.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

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

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 assistance 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.

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. Patients should also be cautioned to exercise care when driving or operating machinery due to the potential for impaired alertness.

Patients should be instructed to discontinue use 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 or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition that requires medical evaluation.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if they have a history of liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use.

Finally, patients should be encouraged to speak with their doctor or pharmacist before using this product if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with the product and increase the risk of adverse effects.

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

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 healthcare professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, 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.

View product document (PDF)