Strawberry Cough Drops

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold. Additionally, it provides temporary relief from occasional minor irritation and sore throat.

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

Dosage and Administration

Adults and children aged 5 years and older are instructed to allow 2 drops to dissolve slowly in the mouth, one at a time. This process may be repeated every 2 hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is recommended to consult a doctor prior to administration.

The route of administration is oral, with the method involving the slow dissolution of the drops in the mouth. The frequency of administration may be adjusted based on individual needs or as advised by a healthcare provider.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, patients should discontinue use and consult a healthcare professional if they have a severe sore throat or if irritation, pain, or redness lasts or worsens. If a sore mouth does not improve within 7 days, medical advice should be sought.

Warnings and Precautions

Patients should be closely monitored for the following conditions and symptoms, which may indicate the need for medical intervention.

Sore Throat Warning Healthcare professionals should advise patients to seek prompt medical attention if they experience a severe sore throat that persists for more than 2 days, particularly if it is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms related to a sore mouth do not show improvement within 7 days, patients should be referred to a dentist or physician for further evaluation.

Cough Monitoring Patients should discontinue use and consult a healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may suggest the presence of a serious condition that requires further investigation.

Sore Throat and Mouth Symptoms In cases where a sore throat is severe, or if there is ongoing irritation, pain, or redness that lasts or worsens, patients should be advised to stop use and seek medical advice. Furthermore, if symptoms related to a sore mouth do not improve within 7 days, a consultation with a healthcare professional is warranted.

Regular monitoring of these symptoms is essential to ensure patient safety and to facilitate timely medical intervention when 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, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting attention include a persistent cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may also suggest the presence of a serious underlying condition. Patients should discontinue use and consult a healthcare professional if they experience severe sore throat, or if irritation, pain, or redness lasts or worsens.

Furthermore, patients are advised to seek medical guidance before using this 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).

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of the reach of children. For adults and children aged 5 years and older, the recommended dosage is 2 drops to be dissolved slowly in the mouth, one at a time, with the option to repeat every 2 hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for 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 on 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST. This reporting mechanism is in place to ensure ongoing monitoring of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

Additionally, patients should be informed to seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. If a sore mouth does not show improvement within 7 days, patients should also be encouraged to contact their healthcare provider.

Before using the medication, patients should be advised to consult a doctor 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 the medication is appropriate for their specific health needs.

Storage and Handling

The product is supplied in a secure bag, and it is imperative that the bag remains intact. If the bag is found to be torn or open, the product should not be used.

For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and moisture. It is essential to handle the product with care to maintain its integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)