Giltuss Cough and Cold

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or inhaled irritants. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive. Additionally, this drug provides temporary relief from nasal congestion associated with colds.

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

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 dosage is 2.5 mL every 4 hours. Children aged 2 to 6 years should receive 1.25 mL every 4 hours. For children under 2 years of age, it is advised to consult a doctor before administration.

Healthcare professionals should ensure that the total dosage does not exceed the recommended limits. Specifically, no more than 6 doses should be taken within a 24-hour period. It is important to utilize the dosing cup provided with the product for accurate measurement.

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

Patients should not use this product 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 used for at least 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 in urination due to prostate enlargement. These conditions may increase the risk of adverse effects and warrant careful consideration and monitoring.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. If these symptoms occur, patients are advised to stop use and consult a healthcare professional. 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 occurs with fever, rash, or persistent headache, patients should seek medical advice, as these may indicate a serious underlying condition.

Common adverse reactions may include those related to pre-existing health conditions. Patients should consult a doctor 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.

Drug Interactions

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

Additionally, it is advisable for patients to consult a healthcare professional prior to using this medication if they are concurrently taking other oral nasal decongestants, stimulants, sedatives, tranquilizers, or medications for depression, particularly MAOIs. Monitoring for potential adverse effects is recommended in these cases.

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 6 to under 12 years may be administered a dosage of 2.5 mL every 4 hours. For children aged 2 to 6 years, the recommended dosage is 1.25 mL every 4 hours. It is advised that children under 2 years of age should consult a doctor prior to use.

Healthcare professionals should ensure that the product is kept out of reach of children. In the event of an accidental overdose, immediate medical assistance or contact with a Poison Control Center is essential.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 currently no available data regarding 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 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 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 the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

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 specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

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

Reports of side effects have been received through voluntary reporting and surveillance programs. Patients are advised to contact their healthcare provider for medical advice regarding any adverse events experienced.

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 assistance or contact a Poison Control Center immediately.

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

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, patients should be advised to stop using the medication and seek medical advice if their symptoms do not improve within seven days or if they are accompanied by fever. It is also important to inform patients to stop use and contact a doctor if their cough persists for more than seven days, recurs, or occurs alongside fever, rash, or a persistent headache, as these may indicate a serious condition.

Lastly, patients should be encouraged 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.

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 temperature 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. 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 Cough and Cold, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)