Giltuss Honey Dm Cough

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of cough and persistent cough.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 10 ml every 6 to 8 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 5 ml every 6 to 8 hours. Children aged 4 to under 6 years should receive 2.5 ml every 6 to 8 hours.

It is imperative that no more than 4 doses are taken within a 24-hour period. The enclosed dosing cup should be utilized for accurate measurement, and it is recommended to retain the dosing cup for future use with this product. All dosages are to be measured in milliliters (ml).

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

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 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

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

In the event of an overdose, it is crucial to obtain emergency medical assistance immediately or contact a Poison Control Center without delay. 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 this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in these patients and should not be initiated until at least 2 weeks after discontinuation of the MAOI.

Common adverse reactions may include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. In such cases, patients are advised to stop use and consult a healthcare professional, as these symptoms could indicate a serious underlying condition.

Additionally, patients should seek medical advice prior to using this product if they experience a cough with excessive phlegm (mucus) or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. These conditions may require a different therapeutic approach.

Drug Interactions

The concomitant use of Giltuss Honey DM Cough with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use Giltuss Honey DM Cough while taking 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 Giltuss Honey DM Cough. 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 Honey Dm Cough (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may receive a dosage of 10 ml every 6-8 hours. For children aged 6 to under 12 years, the recommended dosage is 5 ml every 6-8 hours. In children aged 4 to under 6 years, a dosage of 2.5 ml every 6-8 hours is advised. For children under 4 years of age, it is essential to consult a doctor before administration.

Healthcare professionals should ensure that the product is kept out of the reach of children to prevent accidental ingestion.

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 potential 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 use. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation.

In the event of an accidental overdose, immediate medical attention is necessary. Patients should seek professional help or contact a Poison Control center without delay.

Healthcare providers are advised to keep this medication out of reach of children to prevent unintentional exposure.

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

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available data. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of information necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose situations.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria; dizziness; nausea; vomiting; somnolence; confusion; hallucinations; agitation; and respiratory depression. Additionally, cases of serotonin syndrome, potential for abuse and dependence, and withdrawal symptoms upon discontinuation have been noted.

There is an increased risk of adverse effects in patients with pre-existing respiratory conditions, as well as reports of misuse and abuse in certain populations. Severe cases of overdose leading to respiratory depression and death have been documented, along with reports of seizures in patients using high doses. Elderly patients have shown a higher incidence of adverse reactions, including cardiovascular events such as tachycardia and hypertension.

Rare cases of hepatotoxicity, gastrointestinal disturbances (including constipation and diarrhea), and mood changes (such as depression and anxiety) have been reported. Serious skin reactions, including Stevens-Johnson syndrome and anaphylaxis, have also been documented. Other notable adverse events include visual disturbances, increased risk of falls in elderly patients, sleep disturbances, acute kidney injury, and cases of pancreatitis.

Furthermore, there have been reports of thrombocytopenia, myoclonus, tinnitus, and increased intracranial pressure. Cases of cardiac arrest, myocardial infarction, deep vein thrombosis, pulmonary embolism, and stroke have been reported, alongside an increased risk of seizures in patients with a history of seizures.

The data indicate an increased risk of infections and acute respiratory complications, including acute respiratory distress syndrome and acute respiratory failure, particularly in patients with a history of chronic, genetic, congenital, developmental, psychiatric, neurological, metabolic, endocrine, hematological, autoimmune, and infectious conditions.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed 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 underlying condition.

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

Storage and Handling

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

To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, it is recommended to save the carton for complete drug facts and further information regarding the product. Proper handling and storage conditions are crucial for maintaining the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)