Coldaid

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of sore throat.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to place 2 bags in 6 ounces of boiling water and stir the mixture. The liquid should be allowed to cool before consumption. Patients may drink this preparation up to 4 times daily or as directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

There are no contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines to ensure safe and effective use. Exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

In the event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center immediately. Healthcare professionals should emphasize the importance of adhering strictly to the prescribed directions for use, as deviations may lead to adverse effects.

Patients should be advised to discontinue use and consult a physician under the following circumstances: if a sore throat is severe, persists for more than two days, or is accompanied by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting; if symptoms of a sore mouth do not show improvement within seven days; or if there is a persistence or worsening of irritation, pain, or redness. Monitoring for these symptoms is crucial to ensure patient safety and effective management of their condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. In the event of an accidental overdose, it is imperative that patients seek professional assistance or contact a poison control center immediately.

Common adverse reactions include sore throat and sore mouth symptoms. Patients are advised to discontinue use and consult a healthcare professional if the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is crucial for patients to adhere to the directions provided and not to use the medication otherwise than as directed.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Coldaid (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

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 safe use during pregnancy and lactation.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 professional assistance without delay. Healthcare professionals should contact a poison control center immediately for guidance on the appropriate management of the situation.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Monitoring vital signs and observing for any unusual symptoms are critical steps in the management process.

Management procedures may include supportive care and symptomatic treatment as necessary. It is crucial to follow established protocols and guidelines to ensure 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of reach of children to prevent accidental ingestion. It is important to emphasize the necessity of adhering to the recommended dosage and not exceeding it, as doing so may lead to adverse effects.

Patients should be instructed to stop using the medication and consult a doctor if they experience any of the following: a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice promptly.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its integrity and effectiveness. It is essential to keep the product out of reach of children to prevent accidental ingestion. Additionally, the product must be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended method involves placing 2 bags in 6 oz of boiling water, stirring, allowing the liquid to cool, and consuming up to 4 times daily or as directed by a healthcare provider. For children under 12 years of age, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep this and all medications out of the reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)