Acetaminophen/Chlorpheniramine maleate/Phenylephrine hydrochloride

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with colds, the flu, and hay fever or other upper respiratory allergies. The specific symptoms addressed include:

• Minor aches and pains

• Headache

• Sore throat

• Nasal congestion

• Sinus congestion and pressure

• Runny nose and sneezing

• Itching of the nose or throat

• Itchy, watery eyes

Additionally, this drug temporarily reduces fever and promotes nasal and/or sinus drainage. It helps clear nasal passages and decongests sinus openings and passages.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned for this drug.

Dosage and Administration

Adults and children 12 years of age and older are recommended to take 1 to 2 tablets every 4 to 6 hours as needed, while symptoms persist. The total daily dosage should not exceed 10 to 12 tablets in 24 hours, depending on the specific product, or as directed by a healthcare professional. Tablets should be swallowed whole and not crushed, chewed, or dissolved.

For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 hours, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing. Children under 4 years of age should not use these products.

In cases of renal impairment, dosage adjustments may be necessary based on creatinine clearance levels. It is crucial to adhere to the maximum daily dosage limits to avoid the risk of overdose, which can lead to serious health complications.

Contraindications

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If unsure whether a drug contains acetaminophen, consult a doctor or pharmacist.

Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If uncertain whether a prescription drug contains an MAOI, consult a doctor or pharmacist.

Do not use if there has been a history of allergic reaction to this product or any of its ingredients.

Do not use in children under 6 years of age unless directed by a doctor.

Do not use for more than 10 days for pain or more than 3 days for fever unless directed by a doctor.

Avoid alcoholic beverages while using this product.

Do not use to sedate a child or to make a child sleepy.

Warnings and Precautions

Liver Warnings This product contains acetaminophen. Severe liver damage may occur if:

• More than 4,000 mg of acetaminophen is taken in 24 hours.

• Taken with other drugs containing acetaminophen.

• Three or more alcoholic drinks are consumed daily while using this product.

• Specific products may have different maximum daily tablet limits, ranging from 6 to 12 tablets in 24 hours.

Allergy Alerts Acetaminophen may cause severe skin reactions. Symptoms may include:

• Skin reddening

• Blisters

• Rash If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warnings If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

General Precautions Ask a doctor before use if you have:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Glaucoma

• Trouble urinating due to an enlarged prostate gland

• A breathing problem such as emphysema or chronic bronchitis.

Ask a doctor or pharmacist before use if you are:

• Taking the blood-thinning drug warfarin

• Taking sedatives or tranquilizers.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If unsure, consult a doctor or pharmacist. Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

Stop Taking and Call Your Doctor Stop use and ask a doctor if:

• Nervousness, dizziness, or sleeplessness occur.

• Pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults).

• Fever gets worse or lasts more than 3 days.

• Redness or swelling is present.

• New symptoms occur.

• Severe sore throat occurs or is accompanied by fever, headache, rash, nausea, or vomiting.

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if no signs or symptoms are noticed.

Side Effects

Severe liver damage may occur if acetaminophen is taken in excess of the recommended dosages, which vary by product. The maximum daily amounts for various formulations include:

• 12 tablets in 24 hours for some products (e.g., Coltalin, Extra Fast Coltalin, Cold Medicine).

• 6 to 8 tablets in 24 hours for others (e.g., Resfriol D, Coldtac Ultra, Allergy Multi-Symptom).

• 4,000 mg in 24 hours is a common threshold across many formulations.

Liver damage risk is heightened when acetaminophen is taken with other medications containing acetaminophen or when consuming 3 or more alcoholic drinks daily while using these products.

Allergy Alerts

Acetaminophen may cause severe skin reactions, which can manifest as:

• Skin reddening

• Blisters

• Rash

If any skin reaction occurs, patients should stop use and seek medical help immediately.

Common Adverse Reactions

Patients may experience the following symptoms, which warrant discontinuation of the product and consultation with a healthcare provider:

• Nervousness

• Dizziness

• Sleeplessness

• Pain or nasal congestion worsening or lasting more than 7 days

• Fever worsening or lasting more than 3 days

• Redness or swelling

• New symptoms that could indicate a serious condition

Sore Throat Warning

If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Additional Considerations

Patients should be cautious when using these products if they have:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Glaucoma

• Breathing problems such as emphysema or chronic bronchitis

• Difficulty urinating due to an enlarged prostate gland

Drug Interactions

Patients are advised to consult a doctor or pharmacist before use if they are taking:

• Sedatives or tranquilizers

• Blood-thinning medications such as warfarin

• Any other medications containing acetaminophen

Overdose Warning

In case of overdose, immediate medical attention is critical. Patients should contact a Poison Control Center or seek medical help right away, even if no symptoms are present.

Drug Interactions

Taking certain medications concurrently can lead to significant interactions that may affect patient safety and treatment efficacy. The following outlines the relevant drug interactions associated with various products containing acetaminophen and warfarin.

Acetaminophen and Warfarin Interactions

• Coltalin and Extra Fast Coltalin both contain warnings against the concurrent use of any other drug containing acetaminophen, as this may increase the risk of severe liver damage. Additionally, taking acetaminophen with warfarin may enhance the anticoagulant effects of warfarin, leading to an increased risk of bleeding. It is advised to monitor International Normalized Ratio (INR) closely when these medications are used together.

• Norel Ad and Allergy products also indicate that acetaminophen may increase the risk of bleeding when taken with warfarin, necessitating careful monitoring of INR levels.

Other Considerations

• Alcohol, sedatives, and tranquilizers may increase drowsiness when taken with products containing acetaminophen, such as those in the Allergy category. Caution is advised when combining these substances.

Summary of Drug Interaction Information

While some products, such as Medique Medicidin D, Physicianscare Allergy, and Childrens Coltalin, do not provide specific drug interaction information, it is essential to remain vigilant regarding potential interactions with acetaminophen and warfarin, as well as other sedative medications.

Pediatric Use

Pediatric patients under 6 years of age should not be given these medications unless directed by a doctor. For children aged 6 to under 12 years, the following dosing guidelines apply:

• Coltalin and Extra Fast Coltalin: Administer 1 tablet every 4 hours while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor. Severe liver damage may occur if more than 5 doses are taken in 24 hours.

• Childrens Coltalin: Administer 4 chewable tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 tablets) in 24 hours, or as directed by a doctor.

• Medique Medicidin D, Otis Clapp Valihist, Norel Ad, and Allergy products: Children under 12 years should consult a doctor before use.

Excitability may occur, especially in children, with all products. In case of overdose, prompt medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided for Coltalin, Extra Fast Coltalin, Norel Ad, Childrens Coltalin, Allergy, and Physicianscare Allergy.

For Medique Medicidin D and Otis Clapp Valihist, it is advised that elderly patients consult a healthcare professional before use if they have any of the following conditions: liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma, chronic bronchitis or emphysema, or difficulty in urination due to prostate enlargement. Additionally, caution is recommended when using this product, as it may cause drowsiness, particularly when combined with alcohol, sedatives, or tranquilizers. Elderly patients should be advised to avoid exceeding the recommended dosage and to seek medical attention if symptoms such as nervousness, dizziness, or sleeplessness occur, or if pain or nasal congestion worsens or persists beyond specified durations.

In cases of overdose, prompt medical assistance is critical for adults, including elderly patients, even if no immediate symptoms are apparent.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the following medications, as there is a lack of specific safety data regarding their use during pregnancy. The medications include Coltalin, Resfriol D, Coldtac Ultra, Allergy Sinus, Antiflu (both powder and tablet forms), Allergy Multi Symptom, Extra Fast Coltalin, Medique Medicidin D, Antigrip, Flonase, and various formulations of Allergy Multi Symptom and Cold Medicine.

The available information consistently advises that pregnant or breastfeeding patients seek professional guidance prior to use. This precaution is essential due to the potential risks and unknown fetal impacts associated with these medications. No specific risk categories or study results have been provided in the available data, underscoring the importance of individualized assessment by healthcare providers.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the following medications if they are pregnant or breastfeeding. This recommendation applies to various formulations, including tablets and chewable forms, across multiple products such as Coltalin, Extra Fast Coltalin, Medique Medicidin D, Norel Ad, and several allergy medications.

There is no specific data provided regarding the excretion of these medications in breast milk or their potential effects on breastfed infants. Therefore, healthcare providers should exercise caution and consider the benefits and risks when prescribing these medications to lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain medications. For instance, in the case of Antiflu, dosage adjustments may be necessary for those with reduced renal function. It is recommended that renal function tests be monitored regularly in patients with known kidney issues. Specifically, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min, and special monitoring is advised for those with severe renal impairment to prevent potential toxicity.

Other medications, such as Coltalin, Resfriol D, and various allergy medications, do not provide specific information regarding renal impairment, dosage adjustments, or monitoring requirements. Therefore, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these medications to patients with kidney problems.

In summary, while some medications necessitate adjustments and monitoring for patients with renal impairment, others lack specific guidance, underscoring the importance of individualized patient assessment and management.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen due to the risk of severe liver damage. The following guidelines apply:

• Dosage Adjustments: Dosage modifications may be necessary for patients with liver problems. Specifically, patients with severe hepatic impairment may require a reduced dose.

• Maximum Daily Dose: The maximum daily dose of acetaminophen varies by product but generally should not exceed 4,000 mg in 24 hours. Some products specify lower maximums, such as 3,250 mg or 6 tablets, depending on the formulation.

• Alcohol Consumption: Patients should avoid consuming 3 or more alcoholic drinks daily while using these products, as this significantly increases the risk of liver damage.

• Monitoring Requirements: Special monitoring of liver function tests is recommended for patients with hepatic impairment to assess liver health and detect any potential damage early.

• Consultation: Patients are advised to consult a healthcare professional before use if they have liver disease to ensure safe and appropriate use of acetaminophen-containing products.

These precautions are critical to minimize the risk of hepatotoxicity in patients with compromised liver function.

Overdosage

In cases of overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center without delay, regardless of whether symptoms are present. Prompt medical attention is essential for both adults and children.

Potential Symptoms and Risks:

• Severe liver damage may occur if an adult consumes more than 12 tablets of certain products in a 24-hour period, which is the maximum daily dosage. For children, severe liver damage may result from taking more than 5 doses within the same timeframe.

• The risk of severe liver damage is heightened when these products are taken in conjunction with other medications containing acetaminophen or if the individual consumes 3 or more alcoholic drinks daily while using these products.

• Specific products indicate that taking more than 4,000 mg of acetaminophen in 24 hours can also lead to severe liver damage.

Recommended Actions:

• In the event of an overdose, individuals should get medical help or contact a Poison Control Center immediately. The contact number for the Poison Control Center is 1-800-222-1222.

• Continuous monitoring and assessment of the individual’s condition are advised, as symptoms may not be immediately apparent.

Nonclinical Toxicology

Teratogenic Effects

The use of the products is not recommended during pregnancy or breastfeeding without consulting a health professional. This precaution is consistently noted across multiple labels.

Non-Teratogenic Effects

The products may cause excitability, particularly in children. Additionally, drowsiness is a potential side effect, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers.

Nonclinical Toxicology

No specific nonclinical toxicology information is provided in the available data for any of the products.

Animal Pharmacology and Toxicology

There is a lack of detailed animal pharmacology and toxicology information across all reviewed labels.

Storage and Handling

Coltalin and Extra Fast Coltalin are supplied in tablet form. They should be kept tightly sealed and stored below 25°C (77°F) in a dry place, away from direct sunlight.

Resfriol D, Coldtac Ultra, Flonase, and several Allergy Multi Symptom products are also available as tablets. These should be stored at room temperature between 20-25°C (68-77°F), with excursions permitted between 15°C - 30°C (59°F - 86°F). It is important to avoid excessive heat and humidity. Additionally, tamper-evident packaging is required; do not use if the package or blister unit is open or shows any signs of tampering.

Antiflu is available in powder form for solution, but no specific storage or handling information is provided.

Allergy Multi Symptom products, including coated tablets, should be stored between 20°-25°C (68°-77°F) in a dry place. The carton should be retained for complete product information and warnings.

Norel Ad is supplied as multilayer tablets and should be stored at 20°-25°C (68°-77°F).

Medique Medicidin D, Otis Clapp Valihist, and Physicianscare Allergy are provided in film-coated tablet form. They should be stored at room temperature between 59º-86ºF (15º-30ºC) and should avoid excessive heat and humidity. Tamper-evident sealed packets must be used, and any opened or torn packets should not be used.

Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hcl are available as tablets and should be stored at room temperature between 20-25°C (68-77ºF), with precautions against excessive heat and humidity. Tamper-evident packaging is also required.

Childrens Coltalin is a chewable tablet that should be protected from light and stored between 15 to 30°C (59 to 86°F) in a dry place.