Delsym

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or inhaled irritants. It is also indicated for the reduction of the intensity of coughing and the impulse to cough, thereby facilitating sleep. Additionally, this drug provides temporary relief from minor aches and pains, sore throat, and headache. It is further indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits to avoid the risk of overdose.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that the dosing cup is used exclusively for this product and not for any other medications.

For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should ensure that patients understand the importance of not exceeding 6 doses within a 24-hour period.

Contraindications

The use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

The product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. If there is any doubt about the presence of an MAOI in a current prescription, a healthcare professional should be consulted prior to use.

Additionally, it is essential to adhere to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period (the maximum daily amount), concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

Overdose of acetaminophen can result in liver damage. In cases of suspected overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center without delay, as timely intervention is essential for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken when using this product. Patients should be advised to consult a healthcare provider prior to use if they have liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product. It is critical that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to stop using the product and contact a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or persists for more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a doctor or pharmacist. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have taken one within the past two weeks should avoid this product.

Patients with liver disease, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or cough accompanied by excessive phlegm should seek medical advice before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should consult a healthcare professional prior to use.

Patients are advised to discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

An overdose of this product, defined as taking more than the recommended dose, may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Delsym (acetaminophen and dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. The recommended age for use is 12 years and older. For both adults and pediatric patients aged 12 years and over, the dosing is 20 mL in the dosing cup provided every 4 hours.

In the event of an overdose, it is critical to seek quick medical attention for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, do not require specific dosage adjustments when using this product, as no safety concerns have been identified in the provided data. The product is indicated for use in adults and children aged 12 years and older, suggesting that it may not be appropriate for younger populations.

While there are no specific warnings or precautions related to geriatric patients mentioned, healthcare providers should continue to monitor elderly patients for any potential adverse effects, as is standard practice in this population. It is essential to consider the overall health status and concurrent medications of geriatric patients when prescribing this product.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can mitigate potential complications associated with overdose and improve patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: severe skin reactions, which include skin reddening, blisters, and rash.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days. Additionally, they should stop using the product and consult a doctor if their fever worsens or lasts longer than 3 days, if they experience redness or swelling, or if new symptoms arise. Patients should also be made aware that if their cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. It is important for patients with liver disease to consult their healthcare provider before using this medication. Furthermore, patients with a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, should seek medical advice prior to use. Those experiencing a cough accompanied by excessive phlegm should also consult a healthcare professional. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as exposure to lower temperatures may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Delsym, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)