Acetaminophen/Dextromethorphan hydrobromide/Doxylamine succinate/Phenylephrine…

Uses and Indications

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

• Nasal congestion

• Sinus congestion and pressure

• Minor aches and pains

• Headache

• Fever

• Sore throat

• Runny nose and sneezing

• Cough due to minor throat and bronchial irritation

• Cough to help with sleep (Nighttime use only)

Additionally, this drug reduces swelling of nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose. It also helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive (Daytime use only).

Limitations of Use

• The cough relief for sleep is specifically indicated for nighttime use.

• The assistance in loosening phlegm and making coughs more productive is specifically indicated for daytime use.

Dosage and Administration

Adults and children 12 years and older are recommended to take 30 mL of the solution or 2 caplets with water every 4 hours, not to exceed 4 doses of the solution or 8 caplets in a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a doctor before administration. The use of these products is not recommended for children under 4 years of age.

Healthcare professionals should instruct patients to take the medication only as directed and to utilize the dose cup provided for the solution. It is essential to monitor for potential overdose, adhering strictly to the specified dosage limits.

Contraindications

Use of this product is contraindicated in the following situations:

• In patients who have a known allergy to this product or any of its ingredients.

• In conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should consult a doctor or pharmacist if uncertain about the presence of acetaminophen in their medications.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of stopping such medication. Patients should verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

• Concurrent use of daytime and nighttime formulations is not recommended.

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 you have:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Glaucoma

• Cough that occurs with too much phlegm (mucus)

• A breathing problem such as emphysema or chronic bronchitis

• Trouble urinating due to an enlarged prostate gland

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

• A sodium-restricted diet

Ask a doctor or pharmacist before use if you are:

• Taking sedatives or tranquilizers

• Taking the blood thinning drug warfarin

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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

• Fever gets worse or lasts more than 3 days

• Redness or swelling is present

• New symptoms occur

• 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 if patients exceed 4,000 mg of acetaminophen in 24 hours, use other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, 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 two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Common Adverse Reactions

• Nervousness

• Dizziness

• Sleeplessness

• Marked drowsiness (especially in children)

• Excitability (especially in children)

Serious Adverse Reactions

Patients should stop use and consult a doctor if they experience:

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

• Fever worsening or lasting more than three days

• Presence of redness or swelling

• New symptoms occurring

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

Additional Considerations

• Patients should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may increase drowsiness.

• Caution is advised when driving a motor vehicle or operating machinery due to the potential for marked drowsiness.

• In case of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are present.

Pre-existing Conditions

Patients should consult a doctor before use if they have:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Glaucoma

• A breathing problem such as emphysema or chronic bronchitis

• Difficulty urinating due to an enlarged prostate gland

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

Drug Interactions

Patients should inform their doctor or pharmacist if they are taking:

• Sedatives or tranquilizers

• The blood-thinning drug warfarin

Prompt medical attention is essential for any adverse reactions experienced while using this product.

Drug Interactions

Acetaminophen is associated with several significant drug interactions that warrant careful consideration. When used concurrently with warfarin, there is a potential increase in bleeding risk; therefore, it is advised to monitor INR levels closely. Additionally, the use of acetaminophen in conjunction with other products containing acetaminophen or exceeding a total of 4,000 mg within 24 hours may elevate the risk of severe liver damage. This risk is further compounded when acetaminophen is taken alongside three or more alcoholic drinks daily.

Dextromethorphan, another active ingredient in these formulations, should not be used with monoamine oxidase inhibitors (MAOIs) due to the risk of severe hypertension and other serious side effects. It is crucial to avoid the use of dextromethorphan if a patient is currently taking MAOIs or has stopped taking them within the last two weeks.

Furthermore, the concomitant use of sedatives or tranquilizers with these products may enhance drowsiness, particularly during nighttime use. As no specific drug interactions or laboratory test interactions have been reported for some formulations, healthcare providers should remain vigilant and consider individual patient circumstances when prescribing these medications.

Pediatric Use

Children under 12 years should be advised to consult a doctor before use of any cold and flu medications.

Dosing Information:

• Children 4 to under 6 years: Consult a doctor before use.

• Children 6 to under 12 years: 15 mL every 4 hours for liquid formulations; 2 caplets every 4 hours for tablet formulations.

• Adults and children 12 years and over: 30 mL every 4 hours for liquid formulations; 2 caplets every 4 hours for tablet formulations. Do not exceed 8 caplets of Daytime and Nighttime products in any 24-hour period.

Safety Information:

• Children under 4 years: Do not use.

• Excitability and marked drowsiness may occur, particularly with nighttime formulations.

• In case of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are observed.

Storage and Precautions:

• Keep out of reach of children.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this product; however, it is generally advisable for them to consult a healthcare provider prior to use, particularly if they have underlying health conditions or are taking other medications.

While no specific safety concerns are outlined, elderly patients may exhibit increased sensitivity to side effects. Special precautions should be taken for those with liver disease, diabetes, high blood pressure, glaucoma (for the Nighttime formulation), thyroid disease, heart disease, or difficulty urinating due to prostate enlargement.

Marked drowsiness may occur, especially with the Nighttime formulation, and the use of alcohol, sedatives, or tranquilizers can exacerbate this effect. Therefore, caution is recommended when driving or operating machinery.

Pregnancy

Pregnant patients should consult a healthcare professional before using any formulations of cold and flu medications, including solutions and tablets, as the safety of these products during pregnancy has not been established. There is a general recommendation for pregnant or breastfeeding individuals to seek medical advice prior to use, as potential risks and fetal impacts are not fully characterized. It is essential for healthcare providers to evaluate the benefits and risks on a case-by-case basis when considering treatment options for pregnant patients experiencing cold and flu symptoms.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any products indicated for cold and flu relief, including solutions and film-coated tablets. The safety of these medications during breastfeeding has not been established, and there is a potential for excretion into breast milk.

Breastfed infants may be at risk for adverse effects if the lactating mother consumes these medications. Therefore, it is crucial for healthcare providers to evaluate the benefits and risks associated with the use of such products in breastfeeding mothers.

Renal Impairment

Patients with renal impairment should exercise caution when using products indicated for cold and flu relief, particularly those in tablet or solution form. It is advised that patients consult a healthcare professional prior to use if they experience difficulty in urination due to an enlarged prostate gland.

While several labels emphasize the importance of seeking medical advice under these circumstances, there is a notable absence of specific information regarding dosage adjustments, monitoring, or safety considerations for individuals with reduced kidney function across multiple products. This lack of guidance suggests that healthcare providers should carefully evaluate the appropriateness of these medications for patients with renal impairment, considering the potential risks associated with their use.

In summary, while some products recommend consulting a doctor for urinary difficulties, there is no detailed information available regarding renal impairment, necessitating a cautious approach in prescribing these medications to affected patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen. It is advised that they consult a healthcare professional prior to use, particularly if they have liver disease.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using these products.

Monitoring of liver function may be warranted in patients with existing liver conditions, and healthcare providers should evaluate the appropriateness of acetaminophen use in this population to mitigate the risk of hepatotoxicity.

Overdosage

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

Symptoms of overdose may include severe liver damage, particularly in cases where acetaminophen is involved. This product contains acetaminophen, and severe liver damage can occur if more than 4,000 mg of acetaminophen is ingested within a 24-hour period. Additionally, the risk of severe liver damage increases if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the individual consumes three or more alcoholic drinks daily while using this product.

Monitoring for symptoms of overdose is essential, and healthcare professionals should be alerted to any potential signs of liver damage or other adverse effects. Immediate intervention is necessary to mitigate the risks associated with overdose and to ensure the safety and well-being of the affected individual.

Nonclinical Toxicology

Teratogenic Effects

The use of the products is cautioned against during pregnancy or breastfeeding, and it is advised to consult a health professional before use.

Non-Teratogenic Effects

Excitability may occur, particularly in children, and marked drowsiness has been reported. Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, immediate cessation of use and medical consultation is recommended. Users are also advised to seek medical attention if severe sore throat persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. Other symptoms warranting medical consultation include worsening pain, nasal congestion, or cough lasting more than seven days, fever lasting more than three days, presence of redness or swelling, occurrence of new symptoms, or cough returning with rash or headache lasting.

Nonclinical Toxicology

No specific nonclinical toxicology data has been provided in the available product inserts.

Animal Pharmacology and Toxicology

There is no specific animal pharmacology and toxicology data available in the provided product information.

Storage and Handling

The products are supplied in various forms, including solutions and film-coated tablets.

Packaging Configurations:

• Solutions are available for the Daytime Nighttime Severe Cold and Flu and Basic Care Daytime Severe Cold and Flu.

• Tablets are offered in film-coated form for Severe Cold and Flu Relief, Cold and Flu, Severe Cold and Flu Plus Congestion, and Daytime, Nighttime Severe Cold and Flu Relief.

Storage Conditions:

• Solutions should be stored at a temperature range of 20-25°C (68-77°F).

• Film-coated tablets are to be stored at 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F).

Handling Requirements:

• All tablet products are tamper evident. They should not be used if the outer package is opened or if the blister is torn or broken.

• Expiration dates and lot numbers can be found on the end flap of the packaging.