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, sore throat, fever, 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 and administration guidelines.

For adults and children aged 12 years and older, the recommended 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 an overdose may occur.

Patients should utilize only the dosing cup provided with the product for measurement; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to ensure proper administration.

For children under 12 years of age, the product is not indicated and should not be used.

When patients are using other Day Time or Night Time products, they must carefully read each label to confirm the correct dosing to 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 drug, 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 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 beverages 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 using the product 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 beyond seven 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 taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, 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 excitability, particularly in children, and marked drowsiness may occur. It is advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which 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 seven days, if new symptoms arise, if fever intensifies or lasts more than seven days, if redness or swelling is observed, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms could indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

An overdose warning is in place, as 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

Acetaminophen has the potential to elevate the risk of liver damage when co-administered with other acetaminophen-containing medications or in individuals consuming three or more alcoholic beverages daily. It is advisable to monitor liver function in patients who are using acetaminophen in conjunction with these substances.

Dextromethorphan may enhance drowsiness when used concurrently with alcohol, sedatives, or tranquilizers. Caution is recommended when prescribing this combination, and patients should be advised to avoid activities requiring mental alertness until they are aware of how the combination affects them.

Additionally, the use of this product is contraindicated in patients taking prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. This precaution is critical to prevent serious adverse effects.

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. Caution is advised as excitability may occur, particularly in children.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 individuals.

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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a total of 4,000 mg of acetaminophen within a 24-hour period, particularly if they are also taking other medications that contain acetaminophen or consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at increased risk for liver damage. Immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are present.

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 advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Recommended Actions

Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. The risk of liver damage necessitates a proactive approach to management, emphasizing the importance of early intervention.

Potential Symptoms

While specific symptoms of overdose may vary, the potential for liver damage underscores the need for vigilance. Healthcare providers should be prepared to assess and monitor patients for any signs of hepatic impairment following an overdose.

Management Procedures

Upon identification of an overdose, healthcare professionals should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. The involvement of poison control experts can provide additional guidance on the necessary steps to mitigate the effects of the overdose and ensure patient safety.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: severe skin reactions, which include skin reddening, blisters, and rash.

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 or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should consult their doctor or pharmacist before using this product.

It is important to instruct patients not to combine this product with any other medications containing acetaminophen, whether prescription or non-prescription. If patients are unsure about the contents of their medications, they should seek clarification from a healthcare professional.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days. They should also seek medical advice if new symptoms arise, if fever worsens or lasts beyond seven days, or if there is any redness or swelling. Additionally, patients should be cautioned to stop use and consult a doctor if a cough recurs or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children, and marked drowsiness may occur. Therefore, patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should also be exercised when driving or operating machinery.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also 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

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. Patients should be warned about the risks of overdose, which can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised, 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.

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