Theracare Medicated Chest Rub

Description

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

Uses and Indications

This drug is indicated for the temporary relief of throat and chest cough. It also provides temporary relief from nasal congestion associated with the common cold. Additionally, this drug is effective in temporarily alleviating aching muscles and minor aches and pains.

Limitations of Use: This drug is intended for short-term use and should not be used as a substitute for professional medical advice or treatment for underlying conditions.

Dosage and Administration

Adults and children aged 2 years and older should apply a thick layer of the product to the chest and rub it onto sore, aching muscles. If desired, the area may be covered with a dry soft cloth; however, it is important to keep clothing loose to ensure comfort. This application may be repeated up to three times daily.

For children under 2 years of age, it is advised to consult a physician prior to using this product.

The product is intended for topical application, and the method of administration involves rubbing it onto the affected area. The frequency of application should not exceed three times per day.

Contraindications

The product is contraindicated for oral administration, intranasal use, application on wounds or damaged skin, and use in conjunction with tight bandages. These restrictions are in place to prevent potential adverse effects associated with improper use.

Warnings and Precautions

For external use only; direct contact with the eyes must be avoided. This product is not intended for oral use and should not be applied in the nostrils. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with tight bandages.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of asthma, excessive phlegm (mucus), emphysema, a persistent or chronic cough, or a cough associated with smoking.

During the application of this product, it is critical to avoid heating methods. The product should not be heated, microwaved, or used near an open flame. Additionally, it should not be added to hot water or any container where heating water may cause splattering, which could result in burns.

Patients should be instructed to discontinue use and seek medical advice if muscle aches or pain persist for more than 7 days or if they recur. Similarly, if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or headache that persists, medical consultation is necessary, as these symptoms may indicate a serious condition.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (800-222-1222) is recommended.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience muscle aches or pain that persist for more than 7 days or if these symptoms recur. Additionally, if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a headache that persists, these may indicate a serious underlying condition requiring medical evaluation.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Medicated Chest Rub (camphor (synthetic) , eucalyptus oil, and menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before using this product. For children aged 2 years and older, the recommended application involves rubbing a thick layer on the chest and throat or on sore, aching muscles. If desired, the area may be covered with a dry soft cloth, ensuring that clothing remains loose. This application can be repeated up to three times daily.

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 adverse effects or changes in therapeutic response, 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 maternal health. 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 drug 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Accidental ingestion can occur, and immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at 800-222-1222 for guidance on managing the situation.

Prompt action is crucial in cases of suspected overdosage to mitigate potential health risks. The healthcare provider should assess the patient's condition and provide appropriate interventions based on the severity of the symptoms presented.

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 product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed not to use this product by mouth, in nostrils, on wounds, or on damaged skin. Additionally, it should not be used with tight bandages.

Healthcare providers should counsel patients to discontinue use and consult a doctor if muscle aches or pain persist for more than 7 days or if they recur. Similarly, patients should be advised to stop use and seek medical advice if a cough lasts more than 7 days, returns, or occurs alongside fever, rash, or a headache that persists, as these may indicate a serious condition.

When using this product, patients should be cautioned against heating, microwaving, or using it near an open flame. They should also be informed not to add the product to hot water or any container where heating water may cause splattering, which could result in burns.

Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if they have asthma, excessive phlegm (mucus), emphysema, a persistent or chronic cough, or a cough associated with smoking.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The product is administered topically, with instructions for adults and children aged 2 years and older to apply a thick layer to the chest and rub on sore, aching muscles. If desired, the area may be covered with a dry soft cloth, ensuring that clothing remains loose. This application can be repeated up to three times daily.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or the Poison Control Center contacted at 800-222-1222.

Drug Information (PDF)

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

View product document (PDF)