Maximum Strength Cold Tabs

Description

This product is a maximum strength cold tablet formulation designed for pain relief and fever reduction, as well as providing decongestant, expectorant, and cough suppressant effects. The active ingredients include acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. It is intended to alleviate symptoms such as congestion, sinus pain and pressure, cough, fever, and minor aches and pains.

The product is packaged in tamper-evident packets for safety and convenience, with each packet containing two caplets. A total of 80 caplets are included in the packaging. These quality comfort tablets are specifically formulated and packaged for workplace use, adhering to ANSI Z308.1-2021 standards. This product is not manufactured or distributed by McNeil-PPC, Inc., the owner of the registered trademark Tylenol®. Product #1342.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including headache, fever, 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 the productivity of coughs.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets every 4 hours as needed. It is imperative that they do not exceed a total of 10 caplets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician 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. 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 current prescription, seek guidance from a healthcare professional.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a healthcare provider promptly.

Healthcare professionals should instruct patients to stop using the product and seek medical advice if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; emergence of new symptoms; or a cough that recurs or occurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition.

In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other products containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients may experience severe skin reactions associated with acetaminophen, which can 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 where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients with a history of allergic reactions to this product or any of its ingredients, as well as those currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have stopped taking an MAOI within the past two weeks, should also refrain from using this product.

Patients are advised to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or a persistent cough associated with excessive phlegm, smoking, asthma, chronic bronchitis, or emphysema. Additionally, those taking the blood-thinning medication warfarin should seek guidance from a healthcare professional prior to use.

While using this product, patients must adhere to the recommended dosage and should discontinue use 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 for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this product with any other formulation containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this product is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such therapy. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about the presence of an MAOI in their current medication regimen should consult a healthcare professional prior to use.

Additionally, caution is advised when using this product in conjunction with warfarin, a blood-thinning medication. Patients should seek guidance from a healthcare provider or pharmacist before initiating treatment to ensure safe co-administration and appropriate monitoring of anticoagulation levels.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Cold Tabs (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). 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.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently 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 prescribing information 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the recommended dosage of acetaminophen, which is limited to a maximum of 4,000 mg within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of liver toxicity.

Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver damage. Monitoring of liver function is advised in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is crucial to monitor the patient closely and provide appropriate medical care as needed.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

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 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, or those who have stopped taking an MAOI within the last two weeks, should avoid this product. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be advised to discontinue use 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 for more than 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 also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage. It is important for patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. 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), with permissible excursions between 15°C and 30°C (59°F to 86°F). Care should be taken to avoid exposure to excessive heat and humidity. The product should not be used if the packet is opened or torn, ensuring the integrity of the contents is maintained.

Additional Clinical Information

The medication is administered orally. For adults and children 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. For children under 12 years of age, it is advised to consult a doctor regarding appropriate dosing.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)