Giltuss Hbp Cough and Chest Congestion

Description

No description information is available for the specified 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 the common cold or inhaled irritants. It is effective in reducing the intensity of coughing and decreasing the impulse to cough, thereby facilitating sleep. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, making coughs more productive.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 10 mL administered every 4 hours. For children aged 6 to under 12 years, the dosage is 5 mL every 4 hours. In children aged 2 to under 6 years, the appropriate dosage is 2.5 mL every 4 hours.

For children under 2 years of age, it is advised to consult a doctor before administration.

It is crucial not to exceed the recommended dosage and to limit intake to a maximum of 6 doses within any 24-hour period. A dosing cup should be used for accurate measurement of the liquid formulation.

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 they are uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated while using this product.

Warnings and Precautions

The use of this product is contraindicated in patients 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 should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Prior to using this product, patients should seek medical advice if they experience a cough accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases related to smoking, chronic bronchitis, or emphysema.

It is imperative that patients adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

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

This product should be stored out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of the following adverse reactions and important considerations associated with the use of this product.

Warnings: The product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional prior to use.

Ask a Doctor Before Use: Patients with a cough that produces excessive phlegm (mucus) or those experiencing a persistent or chronic cough, such as that associated with smoking, chronic bronchitis, or emphysema, should seek medical advice before using this product.

Stop Use and Ask a Doctor If: Patients are advised 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.

Additional Adverse Reactions or Important Notes: Pregnant or breastfeeding patients should consult a healthcare professional prior to use. It is crucial to keep this product out of reach of children. In the event of an accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on an MAOI or for a period of two weeks following the discontinuation of an MAOI. The combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Giltuss Hbp Cough and Chest Congestion (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL every 4 hours, while those aged 2 to under 6 years should receive 2.5 mL every 4 hours. For infants and children under 2 years of age, it is advised to consult a doctor prior to administration.

It is crucial to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Geriatric Use

Elderly patients do not have specific recommendations for geriatric use, nor are there dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Giltuss HBP Cough and Chest Congestion. Healthcare providers should consider the overall health status and comorbidities of geriatric patients when prescribing this medication, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advisable, given the general considerations for medication use in this population.

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 regarding 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

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 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 accidental overdose, it is imperative to seek medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific antidote is known, it should be administered as per established protocols.

It is essential for healthcare providers to remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient following an overdose incident.

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

In postmarketing experience, several adverse reactions have been reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, and allergic reactions such as rash, itching, and swelling. Serious side effects have also been documented, notably respiratory depression, particularly in patients with pre-existing respiratory conditions.

Additionally, cases of misuse and abuse have been identified, prompting increased monitoring and recommendations for healthcare providers. Some patients have reported experiencing confusion and hallucinations, especially at higher doses. There have also been instances of serotonin syndrome in patients concurrently using this product with other serotonergic medications. The safety profile of this product remains under ongoing evaluation, and healthcare professionals are encouraged to report any adverse events.

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 accidental overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product should not be used 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, they should refrain from 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.

Healthcare providers should instruct patients to stop using the product and seek medical advice if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Furthermore, healthcare providers should advise patients to consult a doctor before using this medication if they have a cough that produces excessive phlegm (mucus) or if they experience a persistent or chronic cough, such as that associated with smoking, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F).

To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, the product should not be used if the safety seal is broken or missing, as this may compromise its safety and efficacy. Proper handling and storage conditions are crucial for maintaining the quality of the product.

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 essential to keep the medication out of reach of children, and in the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)