Acetaminophen/Chlorpheniramine maleate/Phenylephrine hydrochloride

Description

Coldtac Ultra is available in three different dosage forms: Coldtac Ultra 6C, Coldtac Ultra 12C, and Coldtac Ultra 144C. The product is identified by the following National Drug Codes (NDC): 69729-122-06 for Coldtac Ultra 6C, 69729-122-37 for Coldtac Ultra 12C, and 69729-122-38 for Coldtac Ultra 144C. Each formulation is designed to meet specific therapeutic needs and is manufactured under stringent quality control standards.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever or other respiratory allergies. These symptoms include headache, nasal congestion, sinus congestion and pressure, runny nose, sneezing, minor aches and pains, as well as additional symptoms such as itching of the nose or throat and itchy, watery eyes. The drug also aids in clearing nasal passages and decongesting sinus openings and passages.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet taken with water every 4 to 6 hours as needed. It is imperative that patients do not exceed 6 tablets within a 24-hour period. Tablets must be swallowed whole and should not be crushed, chewed, or dissolved to maintain the integrity of the formulation.

For children aged 4 to 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should also inform patients about the importance of not exceeding the directed dosage and to be aware of the overdose warning associated with this medication.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components.

• For the purpose of inducing sleepiness in children, as this use is not recommended.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen if the following conditions are met: exceeding the maximum daily dosage of 6 tablets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

Overdose of this product can lead to serious health complications. In cases of overdose, immediate medical attention is necessary, and contacting a Poison Control Center is recommended. This is critical for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions should be taken prior to use. Patients should consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin or any sedatives or tranquilizers.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; or if new symptoms arise. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

If patients experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are advised to consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, it is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of such medication. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from use. The product is not intended to induce sleepiness in children.

Before using this product, patients should consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use.

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

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; or if new symptoms arise, as these may indicate a serious condition.

Taking more than the directed dosage can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

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

The use of this medication is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease.

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication, as potential interactions may affect anticoagulation control.

Additionally, caution is advised for individuals using sedatives or tranquilizers concurrently with this medication. The combination may enhance the sedative effects, leading to increased drowsiness. Monitoring for excessive sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to 12 years should consult a healthcare professional before use. The safety and efficacy of this medication have not been established in children under 4 years of age, and its use is not recommended in this population.

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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug 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 exercise caution when using 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. Additionally, patients should avoid concomitant use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to 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

Taking more than the recommended dosage can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. This action is crucial to ensure the safety and well-being of the patient.

Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risks associated with overdosage and improve patient outcomes.

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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, it should not be used to induce sleepiness in children.

Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Patients should also be advised to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and to be aware that excitability may occur, particularly in children. Drowsiness is a potential side effect, and patients should be warned that the use of alcohol, sedatives, or tranquilizers may enhance this effect. Therefore, patients should be advised to avoid alcoholic beverages while using this product.

Patients should exercise caution when driving or operating machinery due to the risk of drowsiness. It is essential for patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in tamper-evident pouches. It is essential to inspect the pouch prior to use; do not utilize the product if the pouch is torn, broken, or exhibits any signs of tampering.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)