Cold Medicine

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headaches. It also provides temporary relief from nasal congestion, sinus congestion and pressure, runny nose, and sneezing.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours as needed. The maximum allowable dosage is 6 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age due to the potential for excessive medication exposure.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to acetaminophen should not use this product due to the risk of severe allergic reactions.

Concurrent use with monoamine oxidase inhibitors (MAOIs) is contraindicated, including during the treatment period and for 2 weeks following discontinuation of MAOIs, as this may lead to significant drug interactions.

The product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, as taking more than 6 tablets within a 24-hour period constitutes the maximum daily amount. Additionally, patients should be cautioned against using this product in conjunction with other medications that contain acetaminophen, as this increases the risk of liver injury. Consumption of three or more alcoholic drinks daily while using this product may also heighten the risk of severe liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In the event of an overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to stop taking the product and consult their healthcare provider if they experience any of the following: redness or swelling, the emergence of new symptoms, feelings of nervousness, dizziness, or sleeplessness, worsening pain or nasal congestion lasting more than 7 days, or a fever that worsens or persists for more than 3 days. Monitoring for these symptoms is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also stop using the product and consult a healthcare professional if they experience redness or swelling, new symptoms arise, or if they feel nervous, dizzy, or sleepless. Furthermore, if pain or nasal congestion worsens or persists for more than 7 days, or if fever intensifies or lasts beyond 3 days, medical advice should be sought.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate gland should consult a healthcare provider. Additionally, those taking blood thinners like warfarin or sedatives and tranquilizers should seek guidance 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 monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment. 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 anticoagulants, such as warfarin, should consult a healthcare professional prior to using this medication. The combination may necessitate careful monitoring of coagulation parameters to avoid potential bleeding complications.

Additionally, caution is advised for individuals using sedatives or tranquilizers alongside this medication. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, increasing the risk of sedation and impairment. Monitoring for excessive sedation is recommended in these cases.

Packaging & NDC

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

Pediatric Use

Children under 12 years of age should not use this product due to the excessive medication content for this age group. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. It is essential to seek quick medical attention for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period. This limit applies not only to the product itself but also to any other medications containing acetaminophen that may be concurrently used.

Additionally, patients should be cautioned against the consumption of 3 or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage. 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 detect any potential adverse effects early.

Overdosage

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

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 6 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 containing 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. Prompt recognition and management of overdosage are crucial to mitigate potential complications associated with liver injury.

Nonclinical Toxicology

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

Severe skin reactions have been reported in association with the use of acetaminophen, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance. Additionally, side effects can be reported to the designated contact number, 1-855-259-1590, available Monday through Friday from 9 AM to 5 PM EST.

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 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 apparent.

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, as this may compromise the integrity of the product.

For optimal storage conditions, the product should be maintained at room temperature, specifically within the range of 59-86°F (15-30°C). Proper adherence to these storage guidelines is essential to ensure the product's efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. The product is not recommended for children under 12 years of age due to excessive medication content.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional prior to use. An overdose warning is in place, as exceeding the recommended dosage may 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 recommended. Quick medical attention is crucial for both adults and children, regardless of the presence of symptoms. Additionally, side effects can be reported to the designated number (1-855-259-1590) during business hours.

Drug Information (PDF)

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

View product document (PDF)