Giltuss Multisymptom Cold and Flu

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headache, minor sore throat pain, and cough due to minor throat and bronchial irritation associated with colds. It also alleviates symptoms of runny nose, sneezing, itchy nose or throat, and itchy watery eyes due to hay fever. Additionally, this drug is effective in reducing nasal and sinus congestion and temporarily lowers fever.

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 to 6 hours, with a maximum of 6 doses allowed within a 2-hour period.

For children aged 6 to under 12 years, the dosage is 5 mL every 4 to 6 hours, not to exceed 5 doses in a 24-hour period.

This medication is not recommended for use in children under 6 years of age.

Healthcare professionals should ensure that patients are advised on the importance of adhering to the specified dosing intervals and maximum dosage limits to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to acetaminophen or any inactive ingredient in this product should not use it. Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is contraindicated, and consumption of alcoholic beverages should be avoided while using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if an adult exceeds 6 doses within a 24-hour period, which is the maximum recommended daily amount. For children, the maximum is 5 doses in the same timeframe. Additionally, caution is warranted when this product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider without delay.

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to stop taking the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by fever, rash, or headache that lasts should also prompt a consultation with a healthcare provider.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if an adult exceeds 6 doses in 24 hours, a child exceeds 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever worsening or lasting more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by fever, rash, or headache lasting longer than expected.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, chronic bronchitis, or chronic cough should consult a doctor or pharmacist before using this product. Furthermore, individuals taking blood thinners like warfarin or those on sedatives or tranquilizers should also seek professional advice prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 5 mL every 4 to 6 hours, with a maximum of 5 doses within a 24-hour period. It is important to note that the use of this medication is not recommended for children under 6 years of age.

Healthcare professionals should be aware that exceeding 5 doses in a 24-hour period may lead to severe liver damage in pediatric patients. Caution is advised when prescribing this medication to ensure adherence to the recommended dosing guidelines.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 no specific data available regarding the excretion of this medication in 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 data 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 information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur under certain conditions, particularly in individuals with compromised liver function.

For adults, the maximum recommended dosage is 6 doses within a 24-hour period. Exceeding this limit can significantly increase the risk of liver damage. Additionally, patients should be advised against taking this product in conjunction with other medications that contain acetaminophen, as this can further elevate the risk of hepatotoxicity.

In pediatric patients, the maximum dosage is limited to 5 doses in a 24-hour period. Careful attention should be given to ensure that this limit is not exceeded.

Furthermore, adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. It is essential for healthcare providers to assess the alcohol consumption habits of patients with hepatic impairment and to provide appropriate counseling regarding the use of this product. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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 depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

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 several adverse reactions associated with the use of the product. Notable among these are severe skin reactions, which may manifest as skin reddening, blisters, rash, hives, and facial swelling. Additionally, respiratory symptoms such as asthma (wheezing) and shock have been reported.

In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Patients should be advised to keep this product out of reach of children. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should not use this product if they are allergic to acetaminophen or any inactive ingredient contained within it. Additionally, they should refrain from using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Patients should also be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or if they have stopped taking an MAOI within the past two weeks. If patients are unsure whether their prescription medication includes an MAOI, they should seek guidance from a healthcare professional.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts longer than three days, or if any redness or swelling occurs. New symptoms that arise should prompt a consultation with a healthcare provider, as should a cough that returns or occurs alongside fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage. They should be made aware that marked drowsiness may occur, and excitability may be experienced, particularly in children. Patients are advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving a motor vehicle or operating machinery.

Patients should be encouraged to consult a doctor or pharmacist before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as chronic bronchitis. They should also seek advice if they have a cough accompanied by excessive phlegm, a chronic cough related to smoking, asthma, or emphysema, or if they experience difficulty urinating due to an enlarged prostate gland. Furthermore, patients should consult a healthcare professional if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). To ensure the integrity of the product, the cap should be closed tightly after each use. Additionally, it is recommended to retain the carton for reference to the complete drug facts.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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