Acetaminophen/Dextromethorphan hydrobromide/Guaifenesin/Phenylephrine hydrochlo…

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including:

• Cough

• Sore throat

• Headache

• Nasal congestion

• Minor aches and pains

• Sinus congestion and pressure

• Sneezing and runny nose (nighttime only)

It helps to clear nasal passages and relieve cough to facilitate sleep. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions to make coughs more productive during the daytime. This drug also temporarily reduces fever.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned.

Dosage and Administration

Adults and children 12 years and over are instructed to take 2 caplets every 4 hours as needed. It is essential that the caplets are swallowed whole; they should not be crushed, chewed, or dissolved. The maximum dosage should not exceed 10 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a doctor before administration.

The route of administration is oral, and the method of taking the medication is to swallow the caplets whole.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use of DAYTIME and NIGHTTIME products is prohibited.

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is not recommended. Patients should consult a doctor or pharmacist if uncertain about the presence of acetaminophen in other medications.

• The product should not be used by individuals 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. Patients should verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

• Individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use.

Warnings and Precautions

Liver Warning This product contains acetaminophen. Severe liver damage may occur if the following conditions are met:

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

• Other drugs containing acetaminophen are used concurrently.

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

Allergy Alert 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 Warning 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 the individual has:

• Liver disease

• Thyroid disease

• Diabetes

• High blood pressure

• Heart disease

• Glaucoma (Nighttime only)

• Cough that occurs with too much phlegm (mucus)

• Difficulty in urination due to enlargement of the prostate gland

• Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• A breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Ask a doctor or pharmacist before use if the individual is:

• Taking the blood-thinning drug warfarin

• Taking sedatives or tranquilizers (Nighttime only)

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.

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

• Nervousness, dizziness, or sleeplessness occur

• Pain, nasal congestion, or cough gets worse or lasts more than 7 days

• New symptoms occur

• Fever gets worse or lasts more than 3 days

• Redness or swelling is present

• Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Side Effects

Severe liver damage may occur with the use of this product, particularly if the following conditions are met:

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

• Other drugs containing acetaminophen are used concurrently.

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

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

• Skin reddening

• Blisters

• Rash

If any of these skin reactions occur, patients should stop use and seek medical help immediately.

Patients are advised to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Serious Adverse Reactions

Patients should stop use and consult a doctor if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Worsening pain, nasal congestion, or cough lasting more than 7 days

• New symptoms that arise

• Fever that worsens or lasts more than 3 days

• Presence of redness or swelling

• Recurrence of cough or occurrence of cough with rash or headache lasting

These symptoms could indicate a serious condition.

Common Adverse Reactions

While using this product, patients may experience:

• Excitability, particularly in children (Nighttime only)

• Marked drowsiness (Nighttime only)

Patients should be cautious when driving a motor vehicle or operating machinery, as alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only). It is recommended to avoid alcoholic beverages during use (Nighttime only).

Precautions

Patients should consult a doctor before use if they have any of the following conditions:

• Liver disease

• Thyroid disease

• Diabetes

• High blood pressure

• Heart disease

• Glaucoma (Nighttime only)

• Cough that occurs with excessive phlegm (mucus)

• Difficulty urinating due to prostate gland enlargement

• Persistent or chronic cough (e.g., smoking, asthma, chronic bronchitis, or emphysema)

• Breathing problems such as emphysema or chronic bronchitis (Nighttime only)

Additionally, patients should ask a doctor or pharmacist before use if they are taking:

• The blood-thinning drug warfarin

• Sedatives or tranquilizers (Nighttime only)

Overdose Information

In case of overdose, patients should seek medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Drug Interactions

There is no specific information regarding drug interactions for Cold and Flu Severe, Severe Cold and Flu, or Severe Cold and Flu Relief. Additionally, there are no reported interactions with laboratory tests for these formulations. Therefore, healthcare professionals should consider the absence of documented interactions when prescribing these medications.

Pediatric Use

Children under 12 years should be advised to consult a doctor before use of this medication. Excitability and marked drowsiness may occur, particularly during nighttime use.

For dosing, adults and children aged 12 years and over may take 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may be at increased risk for adverse effects when using this product. It is advised that healthcare providers be consulted prior to use in patients with liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma (nighttime use only), or difficulty in urination due to prostate enlargement. Additionally, patients with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use.

When administering this product, it is crucial not to exceed the recommended dosage. Marked drowsiness and excitability may occur, particularly in children, and the use of alcohol, sedatives, or tranquilizers can exacerbate drowsiness. Caution is advised when driving or operating machinery, especially during nighttime use.

Elderly patients should be monitored for symptoms such as nervousness, dizziness, or sleeplessness. If pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever lasts more than 3 days, medical attention should be sought. New symptoms, redness, swelling, or a cough that returns with a rash or headache may indicate a serious condition requiring immediate evaluation.

Pregnancy

Pregnant patients should consult a healthcare professional before using any formulations of Cold and Flu, Severe Cold and Flu, or Severe Cold and Flu Relief. The available data indicates that there are no specific studies detailing the risks associated with these medications during pregnancy. However, the general recommendation is to seek professional advice prior to use, particularly for those who are pregnant or breastfeeding. This precaution is essential to ensure the safety of both the patient and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any formulations of Cold and Flu medications, including tablets and film-coated options, during breastfeeding. There is no specific data provided regarding the excretion of these medications in breast milk or their effects on breastfed infants. Therefore, caution is recommended to ensure the safety and well-being of both the mother and the infant.

Renal Impairment

Patients with renal impairment should exercise caution when using the Cold and Flu products, including Cold and Flu Severe, Severe Cold and Flu, and other related formulations. While specific dosage adjustments and monitoring recommendations for patients with reduced kidney function are not provided in the drug inserts, it is advisable for these patients to consult a healthcare professional prior to use.

Additionally, patients experiencing difficulty in urination due to prostate gland enlargement should seek medical advice before using these medications. It is also recommended that patients with renal impairment use caution when driving or operating machinery, as their condition may affect their ability to perform these tasks safely.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which can lead to severe liver damage. The following precautions are advised:

• Patients must not exceed 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications containing acetaminophen is not recommended.

• Consumption of three or more alcoholic drinks daily while using this product may increase the risk of liver damage.

It is essential for patients with liver disease to consult a healthcare professional before using this product to ensure safety and appropriate management. Monitoring of liver function may be warranted in these patients, although specific lab values or parameters are not detailed in the available information.

Overdosage

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

Symptoms of overdose may vary, and monitoring for any potential adverse effects is essential. Healthcare professionals should be prepared to provide supportive care and manage any complications that may arise. It is important to remain vigilant and proactive in the management of overdose situations to ensure the safety and well-being of the affected individual.

Nonclinical Toxicology

Teratogenic Effects

There is no specific information provided regarding teratogenic effects in the available data. However, it is advised that individuals who are pregnant or breastfeeding consult a health professional before use.

Non-Teratogenic Effects

The available data indicates that individuals who are pregnant or breastfeeding should seek advice from a health professional prior to use, although no specific non-teratogenic effects are detailed.

Animal Toxicology

No information is provided regarding animal pharmacology and toxicology in the available data.

Storage and Handling

The products are supplied in tablet form, specifically as film-coated tablets. They should be stored at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F).

Each package is designed to be tamper evident; therefore, it should not be used if the outer package is opened or if the blister is torn or broken. For important information regarding expiration dates and lot numbers, please refer to the end flap of the packaging.