Cough Relief

Description

DEXTROMETHORPHAN HBr is an active ingredient formulated as a cough suppressant, available in a dosage of 15 mg. This medication is designed to relieve cough symptoms for up to 8 hours. It is characterized as non-drowsy and non-narcotic, making it suitable for use without the sedative effects commonly associated with narcotic cough suppressants.

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.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 softgels every 6 to 8 hours as needed. It is imperative that the total dosage does not exceed 8 softgels within a 24-hour period. This product is specifically formulated for adult use and is not intended for children under 12 years of age. Therefore, the use of this product in children under 12 is contraindicated.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm with patients whether their prescription medications contain an MAOI prior to recommending this product.

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

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.

General precautions should be taken when considering this product for patients who present with a cough associated with excessive phlegm (mucus) or those with a chronic cough due to smoking, asthma, or emphysema. It is advisable for healthcare professionals to assess these conditions before recommending the product.

No specific laboratory tests are indicated for monitoring the safe use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include the potential for significant interactions with monoamine oxidase inhibitors (MAOIs). Patients are advised against using this medication concurrently with any prescription MAOI or within two weeks of discontinuing such treatment, as this could lead to severe complications.

Common adverse reactions may include a cough that persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition, and patients should discontinue use and consult a healthcare professional if they experience these signs.

Additionally, patients should seek medical advice prior to using this medication if they have a cough that produces excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

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, certain psychiatric conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Cough Relief (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. The safety and efficacy of this medication have not been established in children within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

Elderly patients should be aware that this product is not intended for use in children under 12 years of age. For adults, including geriatric patients aged 65 and older, the recommended dosage is 2 softgels every 6 to 8 hours, as needed.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, particularly due to the potential for increased sensitivity to medications in this age group. Adjustments to the dosage may be necessary based on individual patient response and tolerance.

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 specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 absence of specific details regarding overdosage for this product (SPL code 34088-5), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise. Symptoms may vary based on the pharmacological profile of the substance involved.

Management Procedures Management of overdosage should be tailored to the individual patient and may include decontamination procedures, such as activated charcoal, if appropriate and within the timeframe of ingestion. Supportive measures should be implemented as needed, and consultation with a poison control center may be beneficial for guidance on specific interventions.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and remain alert to the potential for adverse effects.

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 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.

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

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, or emphysema. This precaution is important to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20–25°C (68–77°F) to ensure optimal stability and efficacy. Care must be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity. Proper storage and handling are essential to preserve the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels every 6 to 8 hours as needed. 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. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)