Coldtac Ultra

Description

COLDTAC ULTRA is a combination medication formulated to provide effective relief from cold and flu symptoms. Each tablet contains 500 mg of Acetaminophen, 4 mg of Chlorpheniramine Maleate, and 10 mg of Phenylephrine HCl. The product is packaged in a total of 144 tablets, organized into 72 packs containing 2 tablets each. The National Drug Code (NDC) for this product is 69729-133-38.

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, sinus congestion and pressure, nasal congestion, runny nose, sneezing, minor aches and pains, as well as additional symptoms such as itching of the nose or throat and itchy, watery eyes.

Furthermore, this drug 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; they 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.

Patients are cautioned against exceeding the directed dosage, and they should 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 advice from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

• For use in children to induce sleep, as this is not an approved indication and may pose safety concerns.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals should be aware of to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a physician promptly.

General Precautions Prior to use, patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, trouble urinating due to an enlarged prostate gland, or a respiratory condition such as emphysema or chronic bronchitis. Furthermore, it is essential to seek guidance from a doctor or pharmacist if the patient is currently taking blood-thinning medications such as warfarin or sedatives/tranquilizers.

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion 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. These may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 tablets within 24 hours, use other medications containing acetaminophen concurrently, or consume 3 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 a patient experiences a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; or if new symptoms arise, as these may indicate a serious condition.

While using this product, patients may experience excitability, particularly in children, as well as drowsiness. 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 consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, trouble urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis. Additionally, patients should seek advice from a healthcare professional if they are taking the blood-thinning medication warfarin or are using sedatives or tranquilizers.

Taking more than the directed dosage can lead to serious health complications. In the event of an overdose, it is crucial for patients 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

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

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional prior to use to assess the need for monitoring or dosage adjustments.

Additionally, the concomitant use of this medication with sedatives or tranquilizers should be approached with caution. The combination may enhance drowsiness, and patients are advised to seek guidance from a healthcare provider before initiating such combinations. Alcohol consumption alongside this medication may also exacerbate drowsiness and should be avoided.

Packaging & NDC

Below are the non-prescription pack sizes of Coldtac Ultra (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 medication is not recommended for children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is 1 tablet with water every 4 to 6 hours as needed, with a maximum of 6 tablets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are present.

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. 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to monitor for any new symptoms that may arise during treatment, as these could indicate a serious underlying condition. If new symptoms occur, patients are advised to discontinue use and seek medical advice promptly.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 6 tablets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dosage of this medication can lead to serious health complications. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay.

Recommended Actions

Prompt medical attention is crucial for both adults and children, regardless of whether any signs or symptoms of overdose are apparent. Healthcare professionals should be prepared to provide supportive care and monitor the patient closely for any potential adverse effects that may arise from the overdose.

Potential Symptoms

While specific symptoms of overdose may vary depending on the substance involved, it is essential to remain vigilant for any unusual or severe reactions. Early recognition and intervention can significantly improve outcomes in cases of overdose.

In summary, the importance of immediate medical intervention cannot be overstated, as timely management is vital in mitigating the risks associated with overdose situations.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

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

Additionally, there is a warning regarding the risks of overdose. Taking acetaminophen in excess of the recommended dosage can lead to serious health complications. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay. 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 keep this product out of reach of children to prevent accidental ingestion. They should emphasize the importance of adhering to the recommended dosage, as taking more than directed can lead to serious health issues. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should consult a doctor or pharmacist for clarification.

It is essential to advise patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, healthcare providers should inform patients that this product is not intended to induce sleepiness in children.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain or nasal congestion worsens or persists beyond seven days, if fever intensifies or lasts more than three days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that drowsiness is a possible side effect. Patients should be cautioned that the use of alcohol, sedatives, or tranquilizers may enhance drowsiness and are advised to avoid alcoholic beverages while using this product. Furthermore, patients should exercise caution when driving or operating machinery.

Healthcare providers should recommend that patients 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, difficulty urinating due to an enlarged prostate gland, or breathing problems such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should seek advice from their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ideally between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. Patients should be informed of the overdose warning, emphasizing that taking more than the directed dose can lead to serious health issues. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial, regardless of whether symptoms are present, for both adults and children.

Drug Information (PDF)

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

View product document (PDF)