Acetaminophen/Chlorpheniramine maleate/Phenylephrine hydrochloride

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 2 tablets every 4 to 6 hours as needed. It is imperative that they do not exceed a total of 10 tablets within a 24-hour period to avoid potential adverse effects.

For children under 12 years of age, the use of this product is contraindicated. Administration in this age group may result in an overdose, which poses a risk of liver damage. Therefore, it is essential that healthcare professionals advise against the use of this medication in children under 12 years.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to acetaminophen.

• Use for more than 10 days is contraindicated unless directed by a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as for 2 weeks following the discontinuation of such medications, due to potential interactions.

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare provider is advised.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is 10 tablets within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should recommend that patients consult a physician prior to using this product if they have any of the following conditions: liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients should be advised to consult a doctor or pharmacist if they are currently taking blood thinners such as warfarin, or sedatives and tranquilizers.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and contact 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 seven days, or a fever that worsens or persists for more than three days.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 10 tablets within 24 hours, use it concurrently with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using the product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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 are advised to stop use and consult a healthcare professional if they experience redness or swelling, new symptoms arise, or if they become nervous, dizzy, or sleepless. Additionally, if pain or nasal congestion worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought.

While using this product, excitability may occur, particularly in children, and drowsiness is a possible side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients with pre-existing conditions such as liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, or those experiencing urinary difficulties due to an enlarged prostate gland, as well as individuals with breathing problems like emphysema or chronic bronchitis, should consult a healthcare provider before use.

Furthermore, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to using this product.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately, as prompt medical attention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI treatment.

Caution is advised when this medication is used in conjunction with anticoagulants such as warfarin. Patients should consult a healthcare professional prior to use if they are currently taking warfarin to assess potential interactions and necessary monitoring.

Additionally, the use of this medication alongside sedatives or tranquilizers warrants consultation with a healthcare provider. The combination may enhance the sedative effects, leading to increased drowsiness. Therefore, patients are advised to avoid alcoholic beverages, as the concurrent use of alcohol with sedatives and tranquilizers may further exacerbate drowsiness.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Medicine. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it may result in an overdose that can lead to liver damage. For patients aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours, with a maximum of 10 tablets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent 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 the maximum daily amount of 10 tablets within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. Due to the risk of overdose, which may lead to liver damage, patients must adhere strictly to the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of the medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that early intervention can significantly impact the outcome of an overdose situation. Monitoring and supportive care may be necessary, and specific management procedures should be initiated based on the clinical presentation and the amount of the substance ingested.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, emphasizing that taking more than the directed amount may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against exceeding the recommended dose and informed that excitability may occur, particularly in children. It is also important to discuss the potential for drowsiness as a side effect. Healthcare providers should recommend that patients avoid the consumption of alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness.

Additionally, patients should be made aware of the need for caution when driving or operating machinery, as drowsiness can impair their ability to perform these tasks safely.

Storage and Handling

The product is supplied in blister packages. It is essential to store the product at room temperature in a dry place to maintain its integrity and effectiveness. Healthcare professionals should ensure that the blister package remains intact; the product should not be used if the blister package is torn, as this may compromise the quality and safety of the medication.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets every 4 to 6 hours, with a maximum of 10 tablets in a 24-hour period. The product is not recommended for children under 12 years of age, as this could lead to an overdose and potential liver damage.

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. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt 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 Medicine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)