Amazon

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it provides temporary relief from symptoms associated with hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat. This drug also aids in controlling the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

Healthcare professionals should instruct patients to measure the dosage using only the dosing cup provided with the product, ensuring that the dosing cup remains with the product for consistent use.

For adults and children aged 12 years and older, the recommended dosage is 20 mL every 6 hours, with a maximum limit of 4 doses within a 24-hour period. It is important to note that this product is not intended for use in children under 12 years of age. Therefore, healthcare providers should advise against administering this medication to individuals in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, should not use this product, nor should they use it within 2 weeks of discontinuing an MAOI due to the risk of serious interactions.

This product is also contraindicated for use in children for the purpose of sedation or inducing sleepiness.

Additionally, it is advised to adhere strictly to the recommended dosage and to avoid the consumption of alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving or operating machinery while using this product.

Warnings and Precautions

The use of this product is contraindicated for sedation in children; it should not be administered to induce sleepiness in pediatric patients. Additionally, it is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric disorders, or Parkinson's disease. The use of this product is also prohibited for a period of two weeks following the cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current medications.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or any chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should also consult with a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should discontinue use and consult a physician if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include marked drowsiness, which may significantly impair the ability to perform tasks that require alertness, such as driving a motor vehicle or operating machinery. Additionally, excitability has been reported, particularly in children, necessitating caution in this population.

Common adverse reactions may include drowsiness, which can be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers. Patients are advised to avoid alcoholic drinks while using this medication, as these substances may increase the risk of drowsiness.

Patients should be instructed to stop use and consult a healthcare professional if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before using this medication, patients should seek medical advice if they have conditions such as trouble urinating due to an enlarged prostate gland, glaucoma, a cough that produces excessive phlegm, or any breathing problems, including chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

This medication should not be used to sedate a child or to induce sleepiness in children. It is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication, as this combination may lead to serious adverse effects.

Drug Interactions

The concomitant use of dextromethorphan with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients currently taking an MAOI or who have discontinued an MAOI within the past two weeks should avoid dextromethorphan due to the potential for serious interactions.

When using doxylamine succinate, caution is advised when combined with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness. Patients should be monitored for increased sedation and advised to exercise caution in activities that require alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Amazon (dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. Children under 12 years should not use this medication. It is contraindicated to use this product to sedate a child or to induce sleepiness. Additionally, excitability may occur, particularly in children, and healthcare professionals should monitor for this adverse effect.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise. It is essential to monitor the patient closely and provide supportive care as needed.

Management procedures should include a thorough evaluation of the patient's condition, including vital signs and any presenting symptoms. Depending on the severity of the overdose, treatment may involve decontamination, administration of antidotes, or other supportive measures as deemed appropriate by the medical team.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned not to exceed the recommended dosage. They should be made aware that marked drowsiness may occur and that the consumption of alcoholic beverages should be avoided, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Providers should emphasize the importance of exercising caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

It is important to inform patients that excitability may occur, particularly in children. They should be advised to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the medication if they have difficulty urinating due to an enlarged prostate gland, have glaucoma, or experience a cough that produces excessive phlegm (mucus). Additionally, those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Lastly, patients taking sedatives or tranquilizers should be advised to consult a doctor or pharmacist before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 ml every 6 hours for adults and children aged 12 years and older. It is contraindicated for 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 crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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