Cough Relief

Description

Dextromethorphan HBr is a cough suppressant formulated to provide relief from coughing. Each dosage unit contains 15 mg of Dextromethorphan HBr. The product is presented in an orange flavor and is alcohol-free, making it suitable for a wide range of patients. The duration of action is approximately 6 to 8 hours, offering extended relief from cough symptoms.

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 as a result of inhaled irritants. Additionally, it is indicated to help alleviate the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 10 mL administered every 6 to 8 hours, with a maximum of 4 doses within a 24-hour period. For children aged 6 to under 11 years, the dosage is 5 mL every 6 to 8 hours, also not to exceed 4 doses in a 24-hour timeframe.

It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times. Prior to administration, the product must be shaken well to ensure proper mixing.

For children under 6 years of age, the product is not recommended for use.

Contraindications

Use of this product is contraindicated in patients 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 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least 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 chronic cough associated with smoking, asthma, or emphysema, or if they experience a cough that produces excessive phlegm (mucus).

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant health risks.

Patients are advised to discontinue use and consult a healthcare professional if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or headache. These symptoms may indicate a serious underlying condition that requires medical attention.

Before initiating treatment, patients should seek medical advice if they have a chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. This ensures prompt evaluation and management of any potential overdose effects.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 11 years may receive a dosage of 5 mL every 6 to 8 hours, with a maximum of 4 doses in a 24-hour period. The product is labeled for use in children aged 6 years and older. However, it is contraindicated in children under 6 years of age.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 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 at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous monitoring of vital signs and clinical status is recommended to ensure patient safety and to facilitate timely interventions as needed.

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 assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of adhering to the prescribed dosage and to avoid using more than directed. This guidance is essential to ensure patient safety and to prevent potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. Prior to use, the product must be shaken well to ensure proper consistency and effectiveness.

To maintain product integrity, it is crucial to observe tamper-evident features. The product should not be used if the carton is opened or if the printed safety seal around the bottle or under the 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)