Giltuss Cough and Cold

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of cough, phlegm, and stuffy nose.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 5 ml administered every 4 hours. For children aged 6 to under 12 years, the appropriate dosage is 2.5 ml every 4 hours. Children aged 4 to 6 years should receive 1.25 ml every 4 hours.

It is imperative that the recommended dosage is not exceeded, and no more than 6 doses should be taken within a 24-hour period. For accurate dosing, a dosing cup should be utilized, with measurements provided in milliliters (ml). For children under 6 years of age, consultation with a healthcare professional is advised prior to administration.

Contraindications

Use of this product is contraindicated in patients who experience nervousness, dizziness, or sleeplessness. Discontinue use and consult a healthcare professional if symptoms do not improve within 7 days or if they are accompanied by fever. Additionally, patients should stop use if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache.

Patients with heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to prostate enlargement should seek medical advice before using this product, unless directed otherwise by a healthcare provider. Caution is also advised for individuals with a cough that produces excessive phlegm, or those with a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, consultation with a healthcare professional is recommended for patients taking other oral nasal decongestants, stimulants, sedatives, tranquilizers, or antidepressants, particularly monoamine oxidase inhibitors (MAOIs).

Warnings and Precautions

Patients should not use this product 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, use is contraindicated for a period of two 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.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or experience difficulty urinating due to prostate enlargement. Caution is also warranted for patients with a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should consult a doctor or pharmacist before use if they are concurrently taking any other oral nasal decongestants, stimulants, sedatives, tranquilizers, or medications for depression, particularly MAOIs.

In the event of an accidental overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, medical attention should be sought, as these may indicate a serious condition.

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 that warrant immediate medical attention include nervousness, dizziness, and sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if any of these symptoms arise. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, patients should seek medical advice, as these may indicate a serious underlying condition.

Before initiating treatment, patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to prostate enlargement should consult a healthcare provider. Furthermore, individuals experiencing a cough with excessive phlegm or those with a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema should also seek medical guidance prior to use.

Patients are encouraged to discuss any concurrent medications with their healthcare provider or pharmacist, particularly if they are taking other oral nasal decongestants, stimulants, sedatives, tranquilizers, or antidepressants, especially MAOIs, to avoid potential interactions and adverse effects.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy, as this may result in serious interactions.

Additionally, it is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any other oral nasal decongestants, stimulants, sedatives, tranquilizers, or medications prescribed for depression, particularly MAOIs. This precaution is essential to mitigate the risk of adverse effects and ensure safe therapeutic outcomes.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may be administered 5 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 2.5 mL every 4 hours. In children aged 4 to 6 years, the dosage is 1.25 mL every 4 hours.

For children under 6 years of age, it is advised to consult a doctor before use to ensure safety and appropriate dosing.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients are advised to consult a healthcare professional before using this medication. It is recommended that women who are pregnant discontinue use of the medication. The potential risks associated with the use of this medication during pregnancy have not been fully established, and caution is warranted to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety and well-being of both the mother and the nursing infant.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to gather a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management of overdose may involve the use of specific antidotes, if available, and symptomatic treatment tailored to the patient's needs. Continuous monitoring and supportive measures should be implemented until the patient is stabilized.

In all cases of suspected overdose, consultation with a poison control center or toxicology expert is advised to ensure appropriate management strategies are employed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of adverse reactions, including allergic reactions such as anaphylaxis, angioedema, and urticaria. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Patients should be advised to seek medical or professional help immediately in the event of an accidental overdose, or to contact a Poison Control Center without delay.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed that if symptoms do not improve within 7 days, or if they are accompanied by fever, a cough that lasts more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, they should seek medical attention, as these may indicate a serious condition.

It is important for patients to consult with their healthcare provider before using this medication if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement. Patients should also be advised to discuss their condition if they have a cough with excessive phlegm (mucus), or if they suffer from a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients should be encouraged to speak with their doctor or pharmacist prior to use if they are currently taking any other oral nasal decongestants or stimulants, sedatives, tranquilizers, or medications for depression, particularly monoamine oxidase inhibitors (MAOIs).

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 between 15-30 °C. The container must be kept tightly closed to ensure the integrity of the product. Additionally, it is advisable to retain the carton for complete drug facts and further information regarding the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)