Adult Long Lasting Cough Relief

Description

No description information is available for the 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.

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 orally every 6 to 8 hours as needed. It is imperative that no more than 8 softgels are consumed within a 24-hour period. This product is specifically formulated for adult use and is not intended for children under 12 years of age.

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.

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 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 prescription medications.

Prior to use, it is essential for patients to seek medical advice if they are experiencing a cough that is productive with excessive phlegm or if they have a chronic cough associated with smoking, asthma, or emphysema. These conditions may require further evaluation and management.

Patients should discontinue use and consult a healthcare provider if their cough 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 more serious underlying condition that necessitates medical attention.

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

This product should be stored 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.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to use.

Before using this product, patients should seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use.

Additionally, 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 at 1-800-222-1222.

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 Adult Long Lasting Cough Relief (dextromethorphan hbr). 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 younger than 12, and its use in this population is contraindicated.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

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

Postmarketing experience has revealed reports of various adverse reactions associated with the use of dextromethorphan HBr. The following events have been documented: dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, rash, pruritus, urticaria, and anaphylaxis. These adverse reactions were reported voluntarily or through surveillance programs, and the frequency of these events is not known.

Patient Counseling

Healthcare providers should advise patients to keep this 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 informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is essential for patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Providers should encourage patients to ask a doctor before using this product if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, or emphysema.

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

For patients who are pregnant or breastfeeding, it is important to recommend that they consult a health professional before using this 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 controlled room temperature of 20-25ºC (68-77ºF). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)