Medicated

Description

This product is a medicated chest rub, available in a 4 oz (113 g) dosage form. It is designed for topical application to provide symptomatic relief.

Uses and Indications

This drug is indicated for the temporary relief of throat and chest cough, as well as nasal congestion associated with the common cold. Additionally, it provides temporary relief from 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 throat, or to sore, 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

Use of this product is contraindicated in the following situations:

Administration by mouth or nostrils is prohibited. Application on wounds or damaged skin is also contraindicated, as is use with light bandages.

Heating the product is not permitted; do not microwave, use near an open flame, or add to hot water or any container that may cause splattering and result in burns.

This product must be kept out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only; direct contact with the eyes should be strictly avoided to prevent irritation or injury.

General precautions must be observed to ensure safety. The product should be kept out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, it is imperative to seek medical assistance immediately or contact a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if muscle aches or pain persist for more than seven days or if they recur. Additionally, if a cough lasts longer than seven days, returns, or is accompanied by fever, rash, or a persistent headache, patients should seek medical evaluation, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with the eyes.

In clinical practice, patients are advised to stop use and consult a doctor if muscle aches or pain persist for more than 7 days or if they recur. Additionally, if a cough lasts more than 7 days, returns, or occurs alongside fever, rash, or a headache that persists, these symptoms may indicate a serious condition requiring medical attention.

Before using this product, patients should seek medical advice if they have a history of asthma, excessive phlegm (mucus), emphysema, a persistent or chronic cough, or a cough associated with smoking.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Medicated (camphor, menthol, eucalyptus oil). 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management 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 assessment of potential risks associated with the compound in these areas.

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. In the event of accidental ingestion, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

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 efficacy and integrity. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

Patients should be advised that the product is for external use only and must not come into contact with the eyes. It should not be ingested, applied to the nostrils, used on wounds or damaged skin, or covered with light bandages. Clinicians should recommend that patients consult a doctor prior to use if they have asthma, excessive phlegm, emphysema, a persistent or chronic cough, or a cough associated with smoking.

The product is administered topically, with a thick layer applied to the chest and throat or sore, aching muscles. Patients may cover the area with a dry soft cloth, ensuring clothing remains loose. This application can be repeated up to three times daily. Patients should be cautioned against heating the product, using it near an open flame, or adding it to hot water, as this may cause burns. They should discontinue use and seek medical advice if muscle pain persists beyond seven days, if cough lasts more than seven days, or if it is accompanied by fever, rash, or headache. Pregnant or breastfeeding individuals should consult a healthcare professional before use, and the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)