Extra Strength with Natural Menthol Glacier Mint Cough Suppressant

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation due to colds or inhaled irritants.

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

Dosage and Administration

Adults and children aged 6 years and older are instructed to dissolve 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional. For children under 6 years of age, it is recommended to consult a doctor before administration.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Healthcare professionals should be aware of the following important considerations regarding the use of this medication.

Patients are advised to discontinue use and consult a physician if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation and management.

No specific warnings, general precautions, or laboratory tests have been identified in the current insert. Therefore, healthcare providers should remain vigilant and exercise clinical judgment when assessing patients for potential adverse effects or complications associated with the use of this medication.

Side Effects

Patients should be aware that there are no specific side effects listed for this product. However, it is important to stop use and consult a doctor if a cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients are advised to seek medical advice before using this product if they have a persistent chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). There are no further adverse reactions or important notes identified in clinical trials or postmarketing experiences.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength with Natural Menthol Glacier Mint Cough Suppressant (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare provider.

Geriatric Use

There is no specific information 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

There is no specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients to ensure safe and effective use of the medication. Dosage adjustments should be guided by creatinine clearance levels, with particular attention given to patients with severe renal impairment, as they may require more significant modifications to their treatment regimen.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials, and there is no available information regarding dosage adjustments, special monitoring, or precautions for this population. Therefore, the safety and efficacy of the medication in patients with compromised liver function remain undetermined. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, considering the lack of data on its use in this population.

Overdosage

In the absence of specific information regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise caution when administering the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient's clinical status and monitor for any potential symptoms that may arise. Although no specific symptoms have been documented, general signs of overdosage may include increased severity of known side effects or unexpected adverse reactions.

Management of an overdosage should involve supportive care tailored to the patient's needs. This may include symptomatic treatment and monitoring of vital signs. In cases where the overdosage is suspected, it is advisable to contact a poison control center or seek guidance from a medical toxicologist for further recommendations on management strategies.

Healthcare professionals are encouraged to report any cases of overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed to discontinue use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, it is important for healthcare providers to encourage patients to seek medical advice before using the medication if they have a persistent chronic cough, particularly if it is associated with smoking, asthma, or emphysema. Patients should also be advised to consult their doctor if their cough is accompanied by excessive phlegm (mucus) to ensure appropriate management and care.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a dry place to maintain its integrity and effectiveness. Proper storage conditions should be adhered to, ensuring that the product is protected from moisture and environmental factors that could compromise its quality.

Additional Clinical Information

The medication is administered orally. For adults and children aged 6 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare professional. For children under 6 years of age, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Extra Strength with Natural Menthol Glacier Mint Cough Suppressant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)