Coldtac Plus

Description

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

Uses and Indications

This drug is indicated for the relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. It effectively alleviates sinus congestion and pressure, facilitating the decongestion of sinus openings and passages, thereby restoring freer breathing.

Additionally, this drug aids in loosening bothersome mucus, promoting drainage of the bronchial tubes, and enhancing the productivity of coughs. It also serves to suppress coughs resulting from minor throat and bronchial irritation due to colds or inhaled irritants.

Furthermore, this drug temporarily relieves minor aches, pains, and fever associated with conditions such as headaches, the common cold, toothaches, backaches, muscular aches, and menstrual cramps.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 tablets every 6 to 8 hours as needed. It is imperative that the total dosage does not exceed 8 tablets within a 24-hour period to avoid potential overdose.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

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

• In 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 such medication, as this may lead to serious drug interactions.

• For durations exceeding 7 days for pain or 3 days for fever, unless specifically directed by a healthcare professional, to prevent potential adverse effects associated with prolonged use.

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 following guidelines to mitigate the risk of liver injury:

• Do not exceed 8 tablets within a 24-hour period.

• Avoid concurrent use with other medications containing acetaminophen, whether prescription or over-the-counter. Patients should be encouraged to consult a healthcare provider or pharmacist if they are uncertain about the presence of acetaminophen in other medications.

• Limit alcohol consumption to fewer than 3 drinks per day while using this product.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

In the event of an accidental overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical intervention 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:

• The emergence of new symptoms.

• Presence of redness or swelling.

• Worsening pain or fever.

• Symptoms of nervousness, dizziness, or sleeplessness.

• A persistent cough or symptoms that do not improve within 7 days, recur, or are accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Regular monitoring and patient education regarding these warnings and precautions are essential for safe use of this product.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of more than 8 tablets in 24 hours, use 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.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, or if pain or fever persists or worsens. Additionally, symptoms such as nervousness, dizziness, or sleeplessness warrant consultation with a healthcare provider. A persistent cough or symptoms that do not improve within seven days, recur, or are accompanied by fever, rash, or persistent headache may indicate a serious condition and should be evaluated by a physician.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a healthcare professional. Furthermore, individuals experiencing a cough with excessive phlegm or a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin are advised to consult a doctor or pharmacist before using this product.

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.

Patients should be advised to consult a healthcare professional prior to using this medication in conjunction with any other drugs if there is uncertainty regarding potential interactions.

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI to avoid serious adverse effects.

Caution is advised when considering the use of this medication in patients who are concurrently taking warfarin, a blood-thinning agent. It is recommended that patients seek guidance from a healthcare provider before initiating treatment to ensure appropriate monitoring and dosage adjustments if necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Coldtac Plus (acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 to 8 hours, with a maximum of 8 tablets in a 24-hour period.

In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population. Regular monitoring and assessment of therapeutic response and adverse effects are advised to ensure safe and effective use in elderly patients.

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 lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available data. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of information necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 8 tablets in a 24-hour period.

• Concurrent use with other medications containing acetaminophen, whether prescription or nonprescription. Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, before combining this product with any other drugs to ensure safety.

Additionally, patients should avoid consuming 3 or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage. Regular monitoring of liver function is recommended for patients with compromised liver function to prevent potential adverse effects.

Overdosage

Severe liver damage may occur with an overdose of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical points regarding overdosage.

Dosage Thresholds for Overdosage The risk of severe liver damage increases significantly if the patient exceeds the following thresholds:

• Taking more than 8 tablets within a 24-hour period.

• Concurrent use with other medications that contain acetaminophen, whether prescription or nonprescription. It is advisable for patients to consult a healthcare provider or pharmacist before combining this product with any other drugs to ensure safety.

Alcohol Consumption Patients consuming three or more alcoholic drinks daily while using this product are at an elevated risk for liver damage. It is essential to advise patients to limit alcohol intake during treatment.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should assess the patient's condition and consider the need for liver function tests and other relevant evaluations. Prompt intervention is crucial to mitigate potential liver damage and ensure appropriate management.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed to verify whether any medications they are taking contain acetaminophen by consulting with a doctor or pharmacist. It is essential to caution patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the past two weeks. If patients are uncertain about their prescription medications, they should be encouraged to ask a healthcare professional.

Patients should be instructed not to use the product for more than 7 days for pain relief or more than 3 days for fever unless directed by a healthcare provider. They should be advised to discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, or if pain or fever persists or worsens. Additionally, patients should be informed to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should also counsel patients to stop using the product and consult a doctor if they have a persistent cough or if symptoms do not improve within 7 days, especially if accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients with specific health concerns should be advised to consult a doctor before using the product. This includes individuals with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland. Patients should also be cautioned to seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in packaging that ensures tamper evidence; it should not be used if the packet is open or torn. For optimal storage, the product must be kept at room temperature, specifically within the range of 59° to 86°F (15° to 30°C). It is essential to avoid exposure to excessive heat and humidity to maintain product integrity.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 to 8 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a healthcare professional before use.

Patients should be counseled to seek advice from a health professional if they are pregnant or breastfeeding. In the event of an accidental overdose, it is crucial to obtain medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)