Olbas Lozenges

Description

Olbas Lozenges are formulated with a maximum strength black currant flavor and are sugar-free, making them suitable for individuals on sugar-controlled diets and vegetarians. Each lozenge contains a blend of powerful vapors, including cooling menthol and eucalyptus, along with vitamin C, designed to provide instant, soothing relief for sore throats and to combat coughs. The lozenges come in a package containing 24 units. The product is manufactured in England by G. R. Lane Health Products Ltd., Gloucester, and is imported and distributed by Penn Herb Co., Philadelphia, PA 19154-3293. For more information, visit www.Olbas.com.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 3 years and older are instructed to allow one lozenge to dissolve slowly in the mouth. This process may be repeated every hour as needed, or as directed by a healthcare professional. For children under 3 years of age, it is recommended to consult a doctor prior to administration.

Contraindications

Use is contraindicated in the following situations:

• Severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting; these symptoms may indicate a more serious condition requiring medical evaluation.

• Persistent or chronic cough associated with smoking, asthma, or emphysema, as these conditions may necessitate alternative therapeutic approaches.

• Cough accompanied by excessive phlegm (mucus), which may indicate an underlying condition that requires further assessment.

• Cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache; these symptoms warrant prompt medical attention.

• Sore mouth symptoms that do not improve within 7 days; this may suggest a need for further evaluation by a healthcare professional.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these symptoms may indicate a serious underlying condition.

Healthcare professionals should exercise caution and advise patients to seek medical advice prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, or emphysema. Additionally, patients with a cough that produces excessive phlegm (mucus) should also consult a doctor before initiating treatment.

Patients should be instructed to discontinue use and contact their healthcare provider if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious condition. Furthermore, if symptoms of a sore mouth do not show improvement within seven days, patients should seek medical attention.

Regular monitoring of symptoms and prompt communication with healthcare providers is essential to ensure safe and effective use of the medication.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may include severe sore throat, particularly if it persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting. In such cases, it is imperative that patients consult a doctor promptly, as these symptoms may indicate a serious condition.

Additional considerations include the need for patients to seek medical advice prior to use if they have a persistent or chronic cough, which may occur in conditions such as smoking, asthma, or emphysema. Furthermore, patients experiencing a cough that is accompanied by excessive phlegm (mucus) should also consult a healthcare professional.

Patients are advised to discontinue use and seek medical attention if their cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may be signs of a serious underlying condition. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients should stop use and consult a doctor.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 3 years and older may use the medication by allowing 1 lozenge to dissolve slowly in the mouth, with the option to repeat every hour as needed or as directed by a healthcare professional. For children under 3 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 the safety of both the mother and the developing fetus.

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 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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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 that if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, they should consult a doctor promptly, as these may indicate a serious condition.

It is important for patients to ask a healthcare professional before using the medication if they have a persistent or chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Patients should also be instructed to stop using the medication and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these could be signs of a serious condition. Additionally, if symptoms of a sore mouth do not improve within seven days, patients should consult a healthcare provider.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. Additionally, it is imperative to keep the product out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 3 years and older, the recommended dosage is to allow one lozenge to dissolve slowly in the mouth, with the option to repeat every hour as needed or as directed by a healthcare professional. For children under 3 years of age, it is advised to consult a doctor before administration.

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

Drug Information (PDF)

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

View product document (PDF)