Dextabs

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.

Dosage and Administration

This product should be used strictly according to the provided directions or as directed by a healthcare professional.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 to 8 hours as needed. It is important not to exceed a total of 8 tablets within a 24-hour period.

This product is not intended for use in children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Therefore, no specific conditions or situations have been identified in which the product should not be used.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if a cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may signal a serious medical condition that requires further evaluation.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this medication. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the medication should not be used for at least 2 weeks after discontinuing an MAOI.

Before using this medication, patients should consult a healthcare professional if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema.

Patients are advised to discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires further evaluation.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use.

This medication should be kept out of reach of children. 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dextabs (dextromethorphan hydrobromide). 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 this age should not use the product.

Geriatric Use

Elderly patients may require careful consideration when using this adult product, as it is not intended for use in children under 12 years of age. While specific dosage adjustments for geriatric patients are not provided, healthcare providers should exercise caution and closely monitor this population for any potential adverse effects or changes in efficacy. It is essential to evaluate the overall health status and comorbidities of elderly patients, as these factors may influence the safety and effectiveness of the treatment. Regular assessment and appropriate dose modifications may be necessary to ensure optimal therapeutic outcomes in this demographic.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to identify any potential symptoms and initiate appropriate management procedures.

Healthcare providers should ensure that they are familiar with the specific management protocols for the substance in question, as these may include supportive care, symptomatic treatment, and, if applicable, the use of antidotes. Continuous evaluation of the patient’s condition is necessary to adjust treatment as required.

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

Reports of serious adverse events associated with the use of this product have been received through voluntary reporting and surveillance programs. Healthcare professionals and consumers are encouraged to report any such events by calling weekdays between 10 a.m. to 4 p.m. CST at 833-289-7626 or by visiting the website www.RoboCough.com.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from areas accessible to children, to ensure their safety.

Storage and Handling

The product is supplied in a configuration that includes a child-resistant cap with a safety seal. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product.

To ensure safety, the product is tamper evident; therefore, it should not be used if the safety seal under the child-resistant cap is broken or missing.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. 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.

Drug Information (PDF)

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

View product document (PDF)