Good Neighbor Long Acting Cough

Description

NDC 46122-784-29. ABC Long-Acting Adult Tussin contains Dextromethorphan HBr as the active ingredient, providing a cough suppressant effect. Each 4 FL OZ (118 mL) bottle delivers 30 mg of Dextromethorphan HBr, offering up to 8 hours of cough relief. The formulation is sugar-free and contains no added alcohol, making it suitable for adults aged 12 and over. The product is packaged in a tamper-evident bottle; do not use if the printed safety seal is broken or missing. A dosage cup is included for accurate administration. Distributed by AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428. For further information, visit www.mygnp.com.

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 advised to take 10 mL every 6 to 8 hours as needed. It is imperative that no more than 4 doses are taken within a 24-hour period. The dosing should be measured exclusively with the dosing cup provided with the product, which should be kept with the product at all times. This formulation is not intended for use in 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 there is uncertainty regarding the presence of an MAOI in their prescription medication.

Warnings and Precautions

It is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, the product should not be taken for a minimum of two weeks following the discontinuation 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 prescription medications.

Patients should seek medical advice prior to using this product if they have a cough that is productive of excessive phlegm (mucus) or if they experience a chronic cough associated with conditions such as smoking, asthma, or emphysema. These conditions may necessitate a different therapeutic approach.

If a patient’s cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, it is crucial to discontinue use of the product and consult a healthcare provider. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center without delay at (1-800-222-1222) for guidance and support.

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.

Common adverse reactions include the need for patients to consult a healthcare professional if they experience a cough that is productive of excessive phlegm or if they have a chronic cough, which may be indicative of underlying conditions such as smoking-related issues, asthma, or emphysema.

Patients are advised to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may suggest the presence of a serious condition that requires further evaluation.

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 minimum 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, 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 Good Neighbor Long Acting Cough (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

Elderly patients may require careful consideration when using this product, as it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 10 mL every 6 to 8 hours.

Healthcare providers should monitor geriatric patients closely for any potential adverse effects, as age-related physiological changes may affect drug metabolism and clearance. It is advisable to assess the individual needs and health status of elderly patients to determine the appropriateness of this dosage regimen. Adjustments may be necessary based on the patient's overall health, concurrent medications, and specific clinical conditions.

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 on 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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 Poison Control Center can be reached at (1-800-222-1222), where trained specialists can provide guidance on the appropriate steps to take.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose 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.

In summary, immediate medical help and consultation with a Poison Control Center are critical components in the management of overdose cases.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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. The following events have been documented: dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, rash, pruritus, urticaria, and anaphylaxis. The frequency of these adverse reactions is not known, and they were reported voluntarily or through surveillance programs.

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 informed that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied with a dosing cup included in the package. It should be stored at room temperature to maintain its efficacy. It is essential to ensure that the printed safety seal on the bottle remains intact; do not use the product if the seal is broken or missing, as this indicates potential tampering. Once opened, the product must be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL every 6 to 8 hours for adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)