Ricola Max Throat Care Swiss Cherry

Description

The SPL code for the product is 34089-3. The product is represented by an image file named "Cropped 9014325_US_NEO_US-MAX_Cherry_34ct_Film_low - Flat File.jpg," which is in JPEG format.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold or inhaled irritants. Additionally, it provides temporary relief from occasional minor irritation and pain due to sore throat or sore mouth.

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 prior to administration. It is important to note that the drops should not be bitten or chewed to ensure proper efficacy and safety.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances:

• If cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If sore mouth symptoms do not improve within 7 days.

• If irritation, pain, or redness persists or worsens.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than two days, particularly if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, as these may indicate a serious underlying condition.

This product is contraindicated in children under 6 years of age unless specifically directed by a healthcare professional.

Healthcare providers should instruct patients to discontinue use and consult a physician if the following occur: a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may suggest a serious health issue. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely intervention if necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, which, if it persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, patients should be advised against using this medication in children under 6 years of age unless specifically directed by a doctor.

Common adverse reactions warranting attention include a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms may indicate a serious underlying condition. Patients should also seek medical advice if a sore mouth does not improve within 7 days or if any irritation, pain, or redness persists or worsens.

Before using this medication, patients should consult a healthcare provider if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

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 Ricola Max Throat Care Swiss Cherry (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication unless directed by a healthcare professional. For children in this age group, it is advised to consult a doctor before use.

For pediatric patients 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 regarding the use of Ricola Max Throat Care Swiss Cherry in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, no specific guidance is provided concerning lactation. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 overdosage, it is important to note that there is no specific information regarding overdosage provided in the available sections of the drug insert.

Healthcare professionals are advised to monitor the patient closely for any potential symptoms that may arise, although specific symptoms related to overdosage have not been detailed.

In the absence of defined overdosage management protocols, standard supportive care should be initiated. This may include symptomatic treatment and monitoring of vital signs. If necessary, healthcare providers should consider consulting a poison control center for further guidance on management strategies tailored to the individual patient's needs.

As always, it is essential to report any overdosage incidents to the appropriate regulatory authorities to contribute to the ongoing assessment of the drug's safety profile.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to discontinue use and consult a doctor if their 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 condition. Additionally, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to encourage patients to consult with their doctor before using the medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This ensures that patients receive appropriate guidance tailored to their specific health conditions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a dry place to maintain its integrity and effectiveness. Proper storage conditions are vital to ensure the product remains within its specified quality parameters throughout its shelf life.

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 before administration. Patients should be instructed not to bite or chew the drop.

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

Drug Information (PDF)

This file contains official product information for Ricola Max Throat Care Swiss Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)