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Astonea Chest Rub

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This product has been discontinued

Active ingredients
  • Eucalyptus Oil 0.012 g/1 g
  • Camphor (synthetic) 0.047 g/1 g
  • Menthol 0.0125 g/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
June 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Eucalyptus Oil 0.012 g/1 g
  • Camphor (synthetic) 0.047 g/1 g
  • Menthol 0.0125 g/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
June 25, 2024
Manufacturer
ASTONEA LABS PRIVATE LIMITED
Registration number
M012
NDC root
77338-321
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from cough caused by minor irritation in the throat and bronchial area, particularly when associated with the common cold. You can apply it to your chest and throat for soothing effects.

Additionally, it helps alleviate minor aches and pains in muscles and joints when applied directly to those areas. This makes it a versatile option for addressing both respiratory discomfort and muscle or joint soreness.

Uses

You can use this product to help relieve a cough caused by minor irritation in your throat and bronchial area, especially when you're dealing with a common cold. Simply apply it to your chest and throat for temporary relief.

Additionally, if you're experiencing minor aches and pains in your muscles and joints, applying this product can provide you with temporary comfort. It's designed to help ease those discomforts, allowing you to feel better throughout your day.

Dosage and Administration

To use this medication effectively, start by applying a thick layer to your throat and chest if you are an adult or a child aged 2 years and older. You can cover the area with a warm, dry cloth if you like, and make sure your clothing is loose around your throat and chest to allow the soothing vapors to reach your nose and mouth. You can use this treatment up to three times a day, or as your doctor advises.

If you are dealing with minor aches and pains in your muscles or joints, apply the medication directly to the affected area. You can do this no more than 3 to 4 times a day. However, please remember that this product is not safe for children under 2 years old, so avoid using it on them.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never take it by mouth, apply it with tight bandages, or use it in your nostrils. Additionally, avoid applying it on wounds or damaged skin, as this can lead to complications.

When using this product, please refrain from heating it, microwaving it, or adding it to hot water. These actions can cause splattering, which may result in burns. Always follow these guidelines to ensure your safety and the effectiveness of the product.

Side Effects

You should be aware of some important side effects and warnings associated with this product. It is meant for external use only, so avoid contact with your eyes, and do not use it by mouth, with tight bandages, in your nostrils, or on wounds or damaged skin. If you experience muscle aches or pains that last more than 7 days, or if a cough persists for more than 7 days, returns, or occurs with fever, rash, or a persistent headache, you should stop using the product and consult a doctor, as these could indicate a serious condition.

If you have a cough that produces a lot of mucus or a chronic cough related to smoking, asthma, or emphysema, it's best to talk to a doctor before using this product. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes and do not use it by mouth. It should not be applied with tight bandages, in your nostrils, or on wounds and damaged skin. If you have a cough with excessive mucus or a chronic cough due to smoking, asthma, or emphysema, consult your doctor before using this product.

While using this product, do not heat, microwave, or mix it with hot water, as this can cause splattering and burns. If you experience muscle aches that last more than 7 days or if your cough persists for more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor. If you are pregnant or breastfeeding, please consult a healthcare professional before use. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical attention. Remember, it’s always better to be safe and get help if you’re unsure.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important to avoid using this product. For children aged 2 years and older, you can apply a thick layer on their throat and chest. It’s helpful to cover the area with a warm, dry cloth and ensure their clothing around the throat and chest is loose. This allows the soothing vapors to reach their nose and mouth effectively. You can use this treatment up to three times a day or as directed by your child's doctor. Always follow your healthcare provider's advice for the best care.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs. Always feel free to ask questions or express any concerns you may have regarding your medications or tests. Your health and safety are the top priority.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You can use this medication topically, applying it to the affected area for minor muscle or joint aches and pains. You may apply it up to three to four times daily, or as directed by your doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

Make sure to keep the medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What does this drug do?

This drug temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold when applied to the chest and throat, and it also relieves minor aches and pains of muscles and joints.

How should I use this drug?

For adults and children 2 years and over, rub a thick layer on the throat and chest, and cover with a warm, dry cloth if desired. You can use it up to three times daily or as directed by your doctor.

Are there any age restrictions for using this drug?

Do not use this drug in children under 2 years of age.

What should I avoid while using this drug?

Do not use this drug by mouth, with tight bandages, in nostrils, or on wounds or damaged skin. Avoid contact with eyes.

What should I do if my symptoms persist?

Stop use and ask a doctor if muscle aches and pains persist for more than 7 days or if a cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store this drug?

Store the drug at room temperature.

Packaging Info

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

Packaging configurations for Astonea Chest Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is classified as a topical analgesic. It is formulated as a cream that appears white to off-white in color. The active ingredients include menthol and camphor. Inactive ingredients consist of water, glycerin, stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sodium hydroxide, methylparaben, propylparaben, and fragrance.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with the common cold when applied to the chest and throat. Additionally, it is indicated for the temporary relief of minor aches and pains of muscles and joints when applied to the affected areas.

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

Dosage and Administration

For adults and children aged 2 years and older, a thick layer of the product should be applied to the throat and chest. If desired, the area may be covered with a warm, dry cloth to enhance the effect. It is recommended to keep clothing loose around the throat and chest to facilitate the inhalation of vapors. This application may be repeated up to three times daily or as directed by a healthcare professional.

For the relief of minor aches and pains in muscles and joints, the product should be applied to the affected area no more than 3 to 4 times daily.

The product is contraindicated for use in children under 2 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

  • Administration by mouth is prohibited.

  • Application with tight bandages is not recommended.

  • Use in the nostrils is contraindicated.

  • Application on wounds or damaged skin is not permitted.

Additionally, during the use of this product, it is essential to avoid heating, microwaving, or adding it to hot water or any container that may involve heating water, as this may lead to splattering and potential burns.

Warnings and Precautions

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

Healthcare professionals should advise patients to consult a doctor prior to use if they experience a cough accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema.

During the application of this product, it is imperative to avoid heating, microwaving, or adding it to hot water or any container that may involve heating water. Such actions may lead to splattering and potential burns.

Patients should be instructed to discontinue use and seek medical advice if muscle aches and pains persist beyond 7 days or if they recur. Additionally, if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, medical consultation is warranted, as a persistent cough may indicate a serious underlying condition.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before use. 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 should be made without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not come into contact with the eyes. It is contraindicated for oral use, application with tight bandages, use in nostrils, or on wounds or damaged skin.

Patients are advised to discontinue use and consult a healthcare professional if muscle aches and pains persist for more than 7 days or if they recur. Additionally, if a cough lasts for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it may indicate a serious condition, and medical advice should be sought.

Before using this product, patients should consult a healthcare provider if they have a cough that produces excessive phlegm (mucus) or if they experience a persistent or chronic cough associated with smoking, asthma, or emphysema.

Furthermore, it is recommended that pregnant or breastfeeding individuals seek advice from a healthcare professional prior to use. The product should be kept out of reach of children, and in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

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 Astonea Chest Rub (camphor (synthetic) , eucalyptus oil, and menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Astonea Chest Rub.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. For children aged 2 years and older, the recommended application involves rubbing a thick layer on the throat and chest, with the option to cover the area with a warm, dry cloth to enhance vapor delivery to the nose and mouth. This can be administered up to three times daily or as directed by a healthcare professional. It is advised to keep clothing loose around the throat and chest to facilitate the effectiveness of the vapors.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 mothers.

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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for oral use and should not be applied with tight bandages. Additionally, it should not be used in the nostrils or on wounds or damaged skin.

Healthcare providers should counsel patients to discontinue use and consult a doctor if muscle aches and pains 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 longer than 7 days, returns, or occurs alongside fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

When using this product, patients must be cautioned against heating it, microwaving it, or adding it to hot water or any container that holds heated water, as this may cause splattering and result in burns.

Providers should also recommend that patients consult a doctor before using the product if they have a cough accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema.

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 and may be applied to the affected area for muscle and joint minor aches and pains up to three to four times daily, or as directed by a healthcare professional. Clinicians should advise 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; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Astonea Chest Rub, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.