Cough and Cold

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of various symptoms associated with common ailments. Specifically, it provides relief from muscular aches and pains, headaches, and fever. Additionally, it alleviates symptoms of upper respiratory allergies, including runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other allergic conditions. The drug also addresses nasal congestion, pressure, and cough resulting from minor throat and bronchial irritation, which may occur with the common cold or exposure to inhaled irritants.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 2 capsules every 4 hours as needed. The maximum dosage should not exceed 12 capsules within a 24-hour period.

For children under 12 years of age, this product is not recommended, as it may deliver a dosage that exceeds the recommended limits and could potentially lead to liver damage.

It is essential to adhere to the general instruction of not exceeding the directed dosage and to refrain from using this product for more than 10 days unless specifically directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Use for more than 10 days for pain or more than 3 days for fever, unless directed by a healthcare professional, to prevent potential adverse effects.

• Known allergy to acetaminophen or any inactive ingredients in this product, as this may lead to severe allergic reactions.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, due to the risk of serious drug interactions.

• Persistent or chronic cough associated with smoking, asthma, or emphysema, or if accompanied by excessive phlegm, unless directed by a healthcare professional, to avoid masking underlying conditions.

• Use in conjunction with sedatives or tranquilizers without prior consultation with a healthcare professional, to mitigate the risk of enhanced sedation or respiratory depression.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they exceed the maximum daily dosage of 12 tablets within a 24-hour period, take this product concurrently with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to using this product.

Healthcare providers should emphasize the importance of adhering to the recommended dosage to prevent overdose, which can lead to liver damage. In cases of suspected overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, regardless of whether they exhibit signs or symptoms of overdose.

Patients should be advised to seek medical attention if symptoms do not improve, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if redness or swelling occurs. New symptoms, a recurrence of cough accompanied by a rash or a headache that lasts, nervousness, dizziness, or sleeplessness should also prompt a consultation with a healthcare provider. Additionally, if fever worsens or lasts for more than 3 days, medical advice should be sought.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic skin reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 12 tablets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms that warrant discontinuation of the product and consultation with a healthcare provider. These include: lack of improvement in symptoms, worsening pain, nasal congestion, or cough lasting more than seven days, presence of redness or swelling, emergence of new symptoms, recurrence of cough accompanied by a rash or persistent headache, nervousness, dizziness, sleeplessness, or a fever that worsens or lasts longer than three days.

Before using this product, patients with pre-existing conditions such as liver disease, breathing problems (e.g., emphysema), glaucoma, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement should consult a healthcare professional. Furthermore, patients taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Additionally, the concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects of this medication, leading to increased drowsiness. Caution is advised, and monitoring for excessive sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cough and Cold (acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this adult product, as it may result in an overdose that can lead to liver damage. For adolescents aged 12 years and older, the recommended dosage is 2 capsules every 4 hours, with a maximum of 12 capsules in a 24-hour period.

Healthcare professionals should be aware that quick medical attention is essential in cases of overdose for both adults and children, even if no signs or symptoms are immediately apparent. Additionally, the use of this product may lead to excitability, particularly in children.

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, 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 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum recommended dosage is 12 tablets in a 24-hour period; exceeding this limit may result in severe liver damage.

Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, the risk of liver damage is heightened in patients who consume three or more alcoholic drinks daily while using this product. It is advisable for patients with compromised liver function to consult with a healthcare professional before using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product, particularly concerning liver function.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 12 tablets within a 24-hour period, which is the established maximum daily dosage. Additionally, the risk of liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are also at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should monitor liver function and consider appropriate interventions based on the severity of the symptoms presented. Early recognition and management are crucial to mitigate potential complications associated with acetaminophen toxicity.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

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

Additionally, reports indicate that excitability may occur, particularly in children, and drowsiness is a potential effect of the product. The concomitant use of alcohol, sedatives, or tranquilizers may enhance the drowsiness effect, necessitating caution when driving or operating machinery, and it is recommended to avoid alcoholic beverages.

Healthcare professionals should be consulted if symptoms do not improve, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if redness or swelling develops. New symptoms, a recurrence of cough accompanied by a rash or a headache lasting longer than usual, nervousness, dizziness, sleeplessness, or a fever that worsens or lasts more than 3 days should also prompt a consultation.

An overdose warning is included, as taking more than the recommended dose may lead to liver damage. In cases of overdose, immediate medical help or contact with a Poison Control Center (1-800-222-1222) is crucial, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important to emphasize the necessity of keeping the medication out of the reach of children to prevent accidental ingestion.

Providers should also inform patients about the risks associated with overdose. Patients must be made aware that taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms of overdose are present.

Storage and Handling

The product is supplied in packaging that must be inspected prior to use. It should not be utilized if the package is torn or damaged.

For optimal storage conditions, the product should be maintained at room temperature, specifically within the range of 15º to 30ºC (59º to 86ºF). Proper handling and storage are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 capsules every 4 hours, with a maximum of 12 capsules within a 24-hour period. It is important to note that this product is not suitable for children under 12 years of age, as exceeding the recommended dosage may lead to liver damage.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the medication out of the reach of children to prevent accidental ingestion.

Drug Information (PDF)

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

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