Acetaminophen/Dextromethorphan hydrobromide

Uses and Indications

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

• Cough due to minor throat and bronchial irritation

• Sore throat

• Headache

• Minor aches and pains

• Fever

The drug may also help reduce the intensity of coughing and control the impulse to cough, aiding in sleep.

Limitations of Use

• The drug is not indicated for the treatment of any specific viral infections or for prolonged use beyond symptomatic relief.

• It is advised for use in individuals with high blood pressure, as some formulations are specifically designed for this population.

No teratogenic or nonteratogenic effects have been mentioned in the available data.

Dosage and Administration

Adults and children 12 years of age and over are recommended to take 30 mL every 4 hours, not to exceed 150 mL (5 doses) in a 24-hour period, unless directed by a doctor. For those using products that require a different dosage, such as tablets or capsules, the recommended dosage is 2 caplets or softgels every 4 hours, with a maximum of 8 caplets or softgels in 24 hours.

Children aged 6 to under 12 years may take 15 mL every 4 hours, while children aged 4 to under 6 years should consult a doctor for appropriate dosing. Children under 4 years of age should not use these products.

For powdered formulations, adults and children 12 years and older should dissolve the contents of one packet in 8 oz. of hot water, sip while hot, and consume the entire drink within 10-15 minutes. This can be repeated every 4 hours, not exceeding 5 packets in 24 hours unless directed by a doctor.

All dosages should be measured using the enclosed dosing cup provided with the product. It is essential to shake well before use for liquid formulations and to ensure that the dosing cup is not used with other products to avoid dosing errors.

Healthcare professionals should advise patients to read all labels carefully when using multiple products to ensure correct dosing and to avoid exceeding the recommended dosages, as overdose may lead to serious health risks.

Contraindications

Do not use in children under 12 years of age. Do not use if allergic to acetaminophen. 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 unsure whether a prescription drug contains an MAOI, consult a doctor or pharmacist.

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

Warnings and Precautions

Liver Warning This product contains acetaminophen. Severe liver damage may occur if the user takes:

• 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.

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.

Stop Use and Ask a Doctor If

• Pain or cough 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.

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

General Precautions Ask a doctor before use if the user has:

• Liver disease.

• Cough that occurs with too much phlegm (mucus).

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

• Trouble urinating due to an enlarged prostate gland.

• A sodium-restricted diet.

• Heart disease, high blood pressure, or diabetes.

Laboratory Tests No specific laboratory tests are mentioned.

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.

Side Effects

Severe liver damage may occur if patients take more than 4,000 mg of acetaminophen in 24 hours, with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using these products.

Allergy Reactions

Acetaminophen may cause severe skin reactions, which can include:

• Skin reddening

• Blisters

• Rash

• Hives

• Facial swelling

• Asthma (wheezing)

• Shock

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

Sore Throat Warning

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.

Additional Warnings

Patients should stop use and consult a doctor if:

• Pain or cough worsens or lasts more than 5 days (children) or 7 days (adults).

• Fever worsens or lasts more than 3 days.

• Redness or swelling is present.

• New symptoms occur.

• Cough returns or occurs with rash or headache that lasts, as these could be signs of a serious condition.

Special Considerations

Patients should ask a doctor before use if they have:

• Liver disease

• A cough that occurs with too much phlegm (mucus)

• A persistent or chronic cough, such as occurs with smoking, asthma, or emphysema

• Any other medical conditions that may affect their ability to use these products safely.

Overdose Warning

Taking more than the recommended dose may cause serious health problems, including liver damage. In case of overdose, patients should seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Drug Interactions

Acetaminophen, a common ingredient in many cold and flu medications, has notable interactions with the anticoagulant warfarin. It may increase the effects of warfarin, leading to an elevated risk of bleeding. Therefore, it is essential to monitor International Normalized Ratio (INR) levels closely when these medications are used together. This interaction is highlighted across several products, including Vicks Dayquil, Robitussin Maximum Strength Severe Cough Plus Sore Throat, and various formulations of Daytime Cold and Flu.

In addition to the interaction with warfarin, it is crucial to avoid using multiple products containing acetaminophen simultaneously. Doing so can significantly increase the risk of severe liver damage. This warning applies to products such as Vicks Dayquil, Cvs Severe Tussin Cf Max, and Walgreens High Blood Pressure, among others.

Dextromethorphan, another common ingredient, should not be used in conjunction with monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping an MAOI due to the potential for severe interactions. This caution is particularly relevant for formulations like Kids Multi Symptom Cold and Flu.

For patients taking warfarin or those who may be at risk for liver damage, it is advisable to consult a healthcare professional before using any of these medications.

Pediatric Use

Pediatric patients under 12 years of age should not use several products, including Theraflu Flu Relief Max Strength, Vicks Dayquil, and various adult formulations such as Robitussin Maximum Strength Severe Cough Plus Sore Throat and Delsym.

Efficacy and Dosing:

• Children 6 to under 12 years:

  • Recommended dose is 15 mL every 4 hours for products like Vicks Dayquil Kids and Cold Flu.

  • For Kids Multi Symptom Cold and Flu, the dose is 10 mL every 4 hours.

• Children 4 to under 6 years:

  • Consult a doctor before use for most products.

  • Specific dosing includes 7.5 mL every 4 hours for Kids Multi Symptom Cold and Flu.

• Children 4 to 5 years:

  • Recommended dose is 5 mL for products like Cvs Childrens and Walgreen Childrens.

Safety and Cautions:

• Children under 4 years: Do not use any of the listed products.

• Maximum daily amount: For children, do not exceed 4 doses (15 mL each) in 24 hours for liquid formulations.

• Overdose warning: Quick medical attention is critical for children in case of overdose, even if no signs or symptoms are noticed.

Consultation Required:

• Parents should consult a doctor if the child has liver disease, persistent or chronic cough, or is taking blood-thinning medications such as warfarin.

• If pain or cough lasts more than 5 days or fever lasts more than 3 days, a doctor should be consulted.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the reviewed products. This includes various formulations such as liquids, tablets, capsules, and powders intended for cold and flu relief. As such, healthcare professionals should exercise caution when prescribing these medications to geriatric patients, considering the absence of data on their safety and efficacy in this population. Regular monitoring and assessment of the patient's response to treatment are recommended, particularly in the absence of established guidelines for elderly patients.

Pregnancy

Pregnant patients should exercise caution when considering the use of various cold and flu relief products. The safety of many of these products during pregnancy has not been established, and it is recommended that pregnant patients consult a healthcare professional before use.

There are potential risks to the fetus associated with the use of these medications, although specific studies or data are not provided in the product inserts. For instance, certain products explicitly state that there may be risks to the fetus, and it is advised to seek medical advice prior to use if pregnant or planning to become pregnant.

No specific dosage modifications for pregnant individuals are mentioned across the reviewed products. Therefore, healthcare providers should evaluate the necessity and safety of these medications on a case-by-case basis, considering the potential benefits against any risks to fetal outcomes.

In summary, pregnant patients are advised to consult with a healthcare professional before using any cold and flu relief products to ensure the safety of both themselves and their developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as many of them do not have specific safety data regarding their use during breastfeeding. There is a potential for excretion of some ingredients in breast milk, which may pose risks to breastfed infants.

For instance, nursing mothers should be particularly cautious with products such as Cvs Children's Suspension and Walgreen Children's Suspension, as both indicate a potential for excretion in breast milk and lack comprehensive studies on their effects on nursing infants.

While some products do not provide specific warnings or recommendations for nursing mothers, such as Kids Multi Symptom Cold and Flu, the absence of information regarding excretion in breast milk or associated risks necessitates a cautious approach.

Overall, the general recommendation across various labels is to seek professional guidance before use during lactation to ensure the safety and well-being of both the mother and the infant.

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 products advise consulting a healthcare professional if the patient experiences difficulty urinating, which may be indicative of underlying urinary tract issues or prostate enlargement. This precaution is noted in the following products:

• Sanatos (Liquid)

• Cold and Flu Relief (Liquid)

• Daytime Cold and Flu (Liquid)

• Ultra Concentrated Daytime Cold and Flu (Capsule, Liquid Filled)

• Mucinex Fast-Max Cold and Flu (Capsule, Liquid Filled)

• Coldtac Severe Cold (Capsule, Liquid Filled)

• Tabcin Active (Capsule, Liquid Filled)

• Daytime Cold and Flu Relief (Liquid)

For all other products reviewed, there is a lack of specific guidance regarding the use in patients with renal impairment. Therefore, it is recommended that patients with compromised kidney function consult their healthcare provider before using these medications to ensure safe and effective use.

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 Limitations:

  • Adults should not exceed 4,000 mg of acetaminophen in 24 hours. Specific products may have lower maximum daily doses, such as 8 softgels or 10 liquid gels, depending on the formulation.

  • Children should not exceed 4 doses (15 mL each) in 24 hours for liquid formulations or 5 doses for other forms, as specified by individual product guidelines.

• Combination Use:

  • Patients must avoid using multiple products containing acetaminophen simultaneously, as this increases the risk of overdose and subsequent liver damage.

• Alcohol Consumption:

  • Consumption of 3 or more alcoholic drinks daily while using these products significantly heightens the risk of liver damage.

• Medical Consultation:

  • Patients with liver disease should consult a healthcare professional before using any acetaminophen-containing products. This recommendation applies to both adults and children.

• Monitoring and Overdose:

  • In the event of an accidental overdose, immediate medical attention is critical. Patients should contact a Poison Control Center or seek professional assistance promptly, even if no symptoms are apparent.

These precautions are essential to minimize the risk of hepatic injury in patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to 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 initially observed.

Taking more than the recommended dose of products containing acetaminophen can lead to severe liver damage. Specifically, adults should not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, and children should not take more than 5 doses in the same timeframe. Additionally, combining acetaminophen with other medications that contain acetaminophen or consuming three or more alcoholic drinks daily while using these products can significantly increase the risk of liver damage.

Symptoms of overdose may not be immediately apparent, which underscores the importance of monitoring and seeking assistance regardless of the presence of symptoms. Individuals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance in managing an overdose situation.

Nonclinical Toxicology

Teratogenic Effects

No information regarding teratogenic effects is provided across the reviewed labels. However, it is noted that for some products, individuals who are pregnant or breastfeeding are advised to consult a health professional before use.

Non-Teratogenic Effects

There is no specific information available regarding non-teratogenic effects for any of the products reviewed.

Nonclinical Toxicology

The reviewed labels do not contain any details pertaining to nonclinical toxicology.

Animal Pharmacology and Toxicology

No information is provided regarding animal pharmacology and toxicology for the products assessed.

Storage and Handling

Theraflu Flu Relief Max Strength is supplied in syrup form. It is important to note that no more than three doses should be taken in any 24-hour period, and the product should not be used if the neckband printed with “SEALED FOR SAFETY” is torn or missing.

Day Time High Blood Pressure Cold and Flu is available as a solution and should be stored at room temperature. Similarly, Sanatos is provided in liquid form and also requires room temperature storage.

Axim Daytime is offered as a liquid and must be stored at room temperature between 15 - 30°C (59 - 86°F); refrigeration is not permitted. It is tamper evident, and should not be used if the shrink band is missing or broken.

Cold and Flu Relief is supplied as a liquid and should be stored between 20-25ºC (68-77ºF) without refrigeration. Axiv Daytime is available in both capsule and liquid-filled forms, requiring storage at 20° - 25 °C (68 °- 77 °F). It is tamper evident, and should not be used if the carton is open or the blister unit is broken.

Alka-Seltzer Plus Cough and Sore Throat Fizzychews are chewable tablets that should be stored at room temperature, avoiding excessive heat above 40°C (104°F). Mucinex Children's Fever Sore Throat and Cough is a solution that should be stored at 20-25°C (68-77°F) and not refrigerated.

Vicks Dayquil is supplied in liquid form and must be stored at no greater than 25°C (77°F) without refrigeration. Vicks Dayquil Kids is also a liquid and should be stored at no greater than 25°C.

Extra Strength Tylenol Severe Cough Plus Sore Throat Day is available as film-coated tablets and should be stored between 20 - 25°C (68 - 77°F). It should not be used if the blister unit is torn or broken.

Daytime Cold and Flu is available in liquid and capsule forms, requiring storage between 20-25ºC (68-77ºF) without refrigeration. The product is tamper evident and should not be used if the carton is open or the blister unit is broken.

Mucinex Fast-Max Cold and Flu is available in tablet and capsule forms, both requiring storage at 20-25°C (68-77°F) while avoiding excessive heat.

Robitussin Maximum Strength Severe Cough Plus Sore Throat is a liquid that should be stored at 20-25°C (68-77°F) without refrigeration.

Theraflu Severe Cold Relief Daytime is supplied as a powder for solution and should be stored at controlled room temperature between 20°C - 25°C (68°F - 77°F), protecting it from heat and moisture.

Childrens Tylenol is a suspension that should be stored between 20-25°C (68-77°F) and should not be used if the carton is opened or if the carton tape or bottle wrap imprinted "TYLENOL" is broken or missing.

All products should be kept out of reach of children, and any tampering or damage to packaging should be taken seriously, as indicated by the tamper-evident features on various products.