Cold Terminator

Description

Cold Terminator is a maximum strength formulation designed for cold relief. Each caplet contains 325 mg of acetaminophen, 10 mg of dextromethorphan hydrobromide, 100 mg of guaifenesin, and 5 mg of phenylephrine hydrochloride. The product is packaged in a total of 150 caplets, with 2 caplets per packet.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including headache, nasal congestion, cough, minor aches and pains, sore throat, and sinus congestion and pressure. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing cough productivity. This drug also temporarily reduces fever.

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.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours as needed. It is imperative that patients do not exceed a total of 10 caplets within a 24-hour period to avoid potential adverse effects.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration 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.

• History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may result in serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms may include blisters, rash, and skin reddening. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General precautions are essential for safe use. Patients should be advised to consult a healthcare provider before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or a cough associated with excessive phlegm. Additionally, those with a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. It is also important to consult a doctor or pharmacist if the patient is taking warfarin, a blood-thinning medication.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay, regardless of whether signs or symptoms are present.

Patients must be advised to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

In addition to liver-related concerns, patients may experience severe skin reactions associated with acetaminophen. Symptoms of such reactions can include blisters, rash, and skin reddening. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for other signs that may warrant discontinuation of the product and consultation with a healthcare provider. These include the onset of nervousness, dizziness, or sleeplessness; worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or persists beyond three days; the presence of redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms could indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters and potential dosage adjustments of warfarin.

This medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing such treatment. The interaction may lead to serious and potentially life-threatening side effects, including hypertensive crises.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Terminator (phenylephrine hydrochloride, acetaminophen, dextromethorphan hydrobromide, guaifenesin). 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 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Caution is advised when administering this medication to younger children.

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 on 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or a cough that recurs or occurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is essential to inform patients that they should not use this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease should avoid this product, as well as for two weeks after discontinuing the MAOI. Patients should be encouraged to ask a doctor or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms or a cough that returns or occurs with a rash or headache that lasts should prompt immediate consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients must not exceed the recommended dosage. It is advisable for patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in tamper-evident sealed packets. It is essential to store the packets at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F).

Healthcare professionals are advised to refrain from using any packets that are opened or torn, as this may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)