Acetaminophen/Dextromethorphan hydrobromide/Doxylamine succinate

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms in both daytime and nighttime formulations.

Daytime Indications

The daytime formulation temporarily relieves the following symptoms:

• Cough due to minor throat and bronchial irritation

• Nasal congestion

• Headache

• Minor aches and pains

• Fever

• Sore throat

Nighttime Indications

The nighttime formulation temporarily relieves the following symptoms:

• Cough due to minor throat and bronchial irritation

• Sore throat

• Headache

• Minor aches and pains

• Fever

• Runny nose and sneezing

Additional Symptom Relief

Both formulations may also help with:

• Reducing swelling of nasal passages

• Promoting nasal and/or sinus drainage

• Restoring freer breathing through the nose

• Loosening phlegm (mucus) and thinning bronchial secretions to make coughs more productive

Limitations of Use

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

Dosage and Administration

Adults and children 12 years and older are advised to take 2 softgels or capsules with water every 4 to 6 hours, depending on the formulation. The maximum dosage should not exceed 4 doses in a 24-hour period. For the liquid formulation, adults and children 12 years and older should take 30 mL every 4 to 6 hours, also not exceeding 4 doses in 24 hours.

Children under 12 years should not use this medication without consulting a healthcare professional. For children aged 4 to under 12 years, it is recommended to seek advice from a doctor regarding the appropriate dosage. Children under 4 years should not use this medication.

All forms of the medication should be swallowed whole; they must not be crushed, chewed, or dissolved. It is essential to follow the dosing instructions carefully to avoid the risk of overdose.

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 before taking this product.

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

Additionally, do not use in children under 12 years of age.

Warnings and Precautions

Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take:

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

• With other drugs containing acetaminophen.

• 3 or more alcoholic drinks every day while using this product.

• For certain products, the maximum daily amount may be 8 softgels or 5 doses for children.

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

• 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

• Nervousness, dizziness, or sleeplessness occur.

• Pain, cough, and nasal congestion get worse or last 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 take more than 4,000 mg of acetaminophen in 24 hours, use other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using these products.

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

Daytime Adverse Reactions

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

• Nervousness, dizziness, or sleeplessness

• Pain, cough, and nasal congestion that worsen or last more than 7 days

• Redness or swelling

• New symptoms

• Fever that worsens or lasts more than 3 days

• Cough that returns or occurs with rash or headache lasting

Nighttime Adverse Reactions

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

• Pain or cough that worsens or lasts more than 7 days

• Fever that worsens or lasts more than 3 days

• Redness or swelling

• New symptoms

• Cough that returns or occurs with rash or headache lasting

These symptoms could indicate a serious condition.

Additional Warnings

• Excitability may occur, especially in children.

• Marked drowsiness may occur; patients should avoid alcoholic drinks and be cautious when driving or operating machinery, as alcohol, sedatives, and tranquilizers may increase drowsiness.

Overdose Warning

Taking more than the recommended dose can cause liver damage. In case of overdose, patients should seek medical help or contact a Poison Control Center immediately (1-800-222-1222). Quick medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Special Considerations

Patients should consult a doctor before use if they have:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Glaucoma

• Cough that occurs with excessive 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

Patients should also consult a doctor or pharmacist before use if they are taking sedatives, tranquilizers, or the blood-thinning drug warfarin.

Drug Interactions

Acetaminophen is a common ingredient in many cold and flu medications and has several important interactions to consider. When used in conjunction with warfarin, a blood thinner, acetaminophen may increase the risk of bleeding. It is advised that healthcare providers closely monitor INR levels in patients taking both medications. Additionally, patients should be cautioned against using multiple products containing acetaminophen simultaneously, as this can lead to severe liver damage. The risk of liver damage is further heightened when acetaminophen is consumed alongside three or more alcoholic drinks daily.

Dextromethorphan, another active ingredient in these formulations, may interact with monoamine oxidase inhibitors (MAOIs). Serious side effects can occur if dextromethorphan is taken with MAOIs or within two weeks of discontinuing them. Therefore, it is crucial to avoid this combination to prevent adverse reactions.

Furthermore, the sedative effects of doxylamine may be amplified when taken with alcohol, sedatives, or tranquilizers, necessitating caution when driving or operating machinery.

In summary, the following interactions should be monitored:

• Acetaminophen and Warfarin: Increased risk of bleeding; monitor INR levels closely.

• Acetaminophen and Alcohol: Increased risk of severe liver damage; avoid concurrent use with three or more alcoholic drinks.

• Dextromethorphan and MAOIs: Risk of serious side effects; avoid use during MAOI treatment and for two weeks after stopping.

• Doxylamine with Alcohol/Sedatives: Increased drowsiness; caution is advised.

Patients are encouraged to consult healthcare professionals before using these medications, especially if they are on other treatments or have underlying health conditions.

Pediatric Use

Pediatric patients aged under 4 years should not use these products. For those 4 to under 12 years, it is advised to consult a doctor before use.

Dosing Information:

• Children 6 to under 12 years: 15 mL every 4 hours for daytime formulations; 30 mL every 6 hours for nighttime formulations.

• Adults and children 12 years and over:

  • Daytime: 30 mL every 4 hours or 2 softgels every 4 hours.

  • Nighttime: 30 mL every 6 hours or 2 softgels every 6 hours.

Safety and Efficacy:

• Excitability may occur, especially in children.

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

• It is important to keep these products out of reach of children.

Cautions:

• Children under 6 years should not use certain formulations.

• If pain, nasal congestion, or cough worsens or lasts more than 5 days in children, a doctor should be consulted.

Geriatric Use

Elderly patients may use this product, which is indicated for adults and children aged 12 years and older. However, no specific dosage adjustments or safety concerns for geriatric patients are detailed in the inserts. It is important for elderly patients to consult a healthcare provider before use, particularly if they have underlying health conditions such as liver disease, heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Marked drowsiness may occur with this product, and the use of alcohol, sedatives, and tranquilizers can exacerbate this effect, which is a significant consideration for elderly patients who may be more sensitive to these side effects. Caution is advised when driving or operating machinery.

Elderly patients should be monitored for any adverse effects, especially if they are taking multiple medications or have pre-existing health conditions. It is recommended to stop use and consult a healthcare provider if symptoms worsen or persist beyond the advised duration.

Pregnancy

Pregnant patients should consult a healthcare professional before using any formulations of Daytime and Nighttime Cold and Flu Relief products, including capsules and liquid-filled forms. The available data indicates that there are no specific studies detailing the risks associated with these products during pregnancy; however, the general recommendation is to seek professional advice when pregnant or breastfeeding.

Healthcare providers should be aware that the safety of these products has not been established in pregnant patients, and potential fetal impacts remain unclear. Therefore, it is prudent to exercise caution and consider alternative treatments that have been evaluated for safety in pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as the safety of these medications during breastfeeding has not been established. There is no specific data provided regarding the excretion of these medications in breast milk or their potential effects on breastfed infants.

Given the lack of detailed information on the pharmacokinetics and safety profiles in lactation, healthcare providers should exercise caution and consider the potential risks versus benefits when recommending these products to breastfeeding mothers. It is essential for lactating mothers to prioritize their health while ensuring the safety of their infants.

Renal Impairment

Patients with renal impairment should be aware that most product labels reviewed do not provide specific information regarding dosage adjustments, monitoring, or safety considerations for those with reduced kidney function.

In particular, several labels indicate the necessity of consulting a healthcare professional if there are issues with urination, especially in the context of an enlarged prostate gland. This precaution is relevant for patients who may experience urinary difficulties, which can be exacerbated by renal impairment.

Additionally, it is advised that patients taking these medications should not exceed the recommended dosage, particularly if they are also on anticoagulant therapy, such as warfarin, as interactions may pose further risks.

Overall, while there is a lack of detailed guidance on the use of these products in patients with renal impairment, the emphasis on consulting a healthcare provider remains critical to ensure safe and effective use.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen. Severe liver damage may occur if the following conditions are met:

• More than 4,000 mg of acetaminophen is taken in a 24-hour period.

• Acetaminophen is taken concurrently with other medications containing acetaminophen.

• Three or more alcoholic drinks are consumed daily while using these products.

It is advised that patients with liver disease consult a healthcare professional before using these products. Monitoring for signs of liver damage is essential, and patients should discontinue use and seek medical advice if they experience worsening pain, cough, or nasal congestion lasting more than 7 days, or if new symptoms arise.

In the event of an overdose, immediate medical attention is critical. Patients should contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent.

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. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Taking more than the recommended dose of this medication can lead to severe liver damage. Specifically, severe liver damage may occur if more than 4,000 mg of acetaminophen is consumed within a 24-hour period, or if this product is taken in conjunction with other medications containing acetaminophen. Additionally, consuming three or more alcoholic drinks daily while using this product can also increase the risk of liver damage.

Symptoms of overdose may not be immediately evident, which underscores the importance of prompt medical evaluation. Monitoring for any potential signs of liver distress is essential, and healthcare professionals may conduct appropriate assessments to determine the extent of any damage.

Nonclinical Toxicology

Teratogenic Effects

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific teratogenic effects were noted in animal studies, and no increase in fetal malformations was observed.

Non-Teratogenic Effects

Marked drowsiness and excitability may occur, particularly in children. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. An allergy alert indicates that acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If a skin reaction occurs, it is recommended to discontinue use and seek medical attention.

Nonclinical Toxicology

No specific nonclinical toxicology information is provided in the inserts. However, studies in animals have indicated that acetaminophen can cause liver damage at high doses and has been associated with adverse developmental outcomes when administered at doses significantly higher than the recommended human dose.

Animal Pharmacology and Toxicology

No specific animal pharmacology and toxicology data are provided in the inserts.

Storage and Handling

Daytime Nighttime Cold Flu Relief products are available in various forms, including capsules and liquid-filled options. The storage conditions for these products vary slightly depending on the specific formulation.

Capsules and liquid-filled forms should be stored between 15-30°C (59-86°F) and must be protected from excessive heat. It is essential to avoid temperatures above 40°C (104°F) for certain formulations.

Solutions, on the other hand, are typically stored at 20-25°C (68-77°F). Some solutions allow for excursions between 15-30°C (59-86°F) but should still be kept away from heat, humidity, and light.

All products should be kept in tamper-evident packaging, and users are advised not to use any product if the outer package is opened or if the blister is torn or broken. It is also important to adhere to the expiration date indicated on the package.