Family Wellness Strawberry Cough Drops

Description

Family Wellness Strawberry Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 30 cough drops, designed for ease of use and convenience. The product features a strawberry flavor, enhancing palatability. The cough drops are intended for use in a family wellness context, suitable for various age groups.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a 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 two 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 of this product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if a patient experiences a severe sore throat or if irritation, pain, or redness lasts or worsens, they should seek medical advice. Furthermore, if a sore mouth does not improve within 7 days, medical consultation is advised.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. These symptoms may indicate a serious underlying condition that requires immediate attention. Additionally, if symptoms of a sore mouth do not show improvement within seven days, the patient should seek evaluation from a dentist or physician.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the following conditions arise: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache. These signs may suggest a serious health issue that necessitates further investigation. Furthermore, if a sore throat is severe or if irritation, pain, or redness persists or worsens, medical consultation is recommended. Lastly, any sore mouth symptoms that do not improve within seven days warrant a prompt assessment by a healthcare provider.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention, particularly in the case of severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, patients are advised to consult a doctor promptly. Additionally, if symptoms of a sore mouth do not improve within 7 days, it is recommended that patients see their dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, which should prompt patients to stop use and seek medical advice if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. Such symptoms could signify a serious underlying condition. Patients should also be cautious if they experience severe sore throat or if irritation, pain, or redness lasts or worsens.

Furthermore, patients are advised to consult a doctor 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

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is 2 drops to be allowed to dissolve slowly in the mouth, one at a time. This dosage may be repeated every two hours as necessary 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. It is advisable to monitor these patients closely for any 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 medication in human 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.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols. Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective treatment and follow-up care.

Overall, vigilance and prompt intervention are key components in managing any suspected overdose situation.

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

Reports of adverse events have been received through voluntary reporting and 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 information contributes to the ongoing monitoring of the product's safety profile.

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 healthcare professional 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. They should also be counseled to contact a doctor if a sore mouth does not show improvement within 7 days.

It is important for healthcare providers to recommend that patients ask a 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).

Storage and Handling

The product is supplied in secure packaging, and it is imperative that it is not used if the bag is torn or open.

For optimal storage and handling, the product should be kept in a cool, dry place, away from direct sunlight and moisture. It is essential to ensure that the storage environment maintains appropriate temperature ranges to preserve the integrity of the product. Special care should be taken to avoid any damage to the packaging, as compromised bags may lead to contamination or reduced efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)