Healthwise Medicated Chest Rub

Description

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

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 2 years and older should apply a thick layer of the product topically to the chest and any sore or aching muscles. If desired, the application may be covered with a dry, soft cloth; however, it is important to ensure that clothing remains loose to avoid discomfort. This application may be repeated up to three times daily, as needed.

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 contraindicated for oral use and should not be applied in the nostrils. It is also not intended for application on wounds or damaged skin, nor should it be used in conjunction with tight bandages.

Healthcare professionals should advise patients to consult a physician 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 imperative to avoid heating, microwaving, or using it near an open flame. Additionally, the product should not be added to hot water or any container where heating water may lead to 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. Furthermore, if a cough lasts longer than 7 days, returns, or is accompanied by fever, rash, or headache that persists, these may indicate a serious underlying condition requiring medical evaluation.

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

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 Healthwise 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

The drug is contraindicated in pregnancy due to potential risks to the fetus associated with its use. Healthcare professionals should be aware that there are significant concerns regarding fetal outcomes when this drug is administered during pregnancy. No specific dosage modifications are recommended for pregnant patients; however, special precautions must be taken when considering the use of this drug in pregnant individuals. It is essential to weigh the potential benefits against the risks to the fetus before prescribing this medication to women of childbearing potential.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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 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 lead to serious health risks. Healthcare professionals should advise patients and caregivers to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if an overdose is suspected.

Prompt action is crucial in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise. It is essential to follow established protocols for the management of overdose cases, which may include supportive care and symptomatic treatment as necessary.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 inform 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 advised not to add the product to hot water or any container where heating water may cause splattering, which could result in burns.

Patients should be encouraged to 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. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically, with a recommended application of a thick layer on the chest and sore, aching muscles for adults and children aged 2 years and older. 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.

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 Healthwise Medicated Chest Rub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)