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Cough and Cold Therapy

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Active ingredients
  • Eucalyptus Oil 1.3 g/100 g
  • Menthol 2.8 g/100 g
  • Camphor (natural) 5 g/100 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 2023
Label revision date
January 27, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Eucalyptus Oil 1.3 g/100 g
  • Menthol 2.8 g/100 g
  • Camphor (natural) 5 g/100 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 2023
Label revision date
January 27, 2025
Manufacturer
Everlaan Organics Inc
Registration number
M012
NDC root
83670-200
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

Maple Organics is a soothing and calming vapor rub designed to provide relief from coughs associated with the common cold. This product works by temporarily alleviating cough symptoms, helping you feel more comfortable during your recovery.

With a net weight of 2 ounces (56 grams), it is formulated to be easy to use and can be a helpful addition to your cold relief routine.

Uses

If you're dealing with a cough caused by the common cold, this medication can help provide temporary relief. It works specifically to ease the discomfort of coughing, allowing you to feel more comfortable as you recover. Remember, it's designed for short-term use to help manage your symptoms while your body fights off the cold.

Dosage and Administration

To use this medication effectively, start by applying it to your throat, chest, and/or the bottoms of your feet. Gently massage the solution into your skin until it disappears completely. If you like, you can cover the area with a warm, dry cloth to enhance the effects.

For the best results, make sure your clothing is loose around your throat and chest. This allows the soothing vapors to reach your nose and mouth more easily. You can use this treatment up to three times a day, or follow your doctor's specific instructions if they differ.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never take it by mouth or use it in your nostrils. Additionally, when using this product, avoid heating it, microwaving it, or adding it to hot water or any container that holds hot water, as this can cause splattering and lead to burns.

By following these guidelines, you can help ensure a safe experience with the product. If you have any questions or concerns, please consult with a healthcare professional.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid using it by mouth or in your nostrils. If you have a persistent cough, especially one related to smoking, asthma, or emphysema, or if your cough comes with excessive mucus, consult a doctor before use.

If your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the product and seek medical advice, as these could be signs of a more serious condition. Additionally, if you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please do not take it by mouth or use it in your nostrils. If you have a persistent or chronic cough—especially if it’s related to smoking, asthma, or emphysema, or if it comes with excessive mucus—be sure to consult your doctor before using this product.

While using this product, avoid heating it, microwaving it, or adding it to hot water, as this can cause splattering and burns. If your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these could be signs of a more serious condition. Always keep this and all medications out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help right away. You can contact a Poison Control Center for guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help immediately. Remember, acting quickly can make a significant difference in the outcome.

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

It's important to keep this medication and all other drugs out of the reach of children. If a child accidentally swallows this medication, you should seek medical help or contact a Poison Control Center right away. Taking quick action can help ensure their safety. Always be vigilant about where medications are stored to prevent any accidental ingestion.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular monitoring and open communication with your healthcare team are essential for safety and effectiveness.

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 should be used 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 you understand how to manage your treatment effectively while considering your kidney health.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

Before using the product, make sure the seal is intact, as it is designed to be tamper-evident. This means that if the seal is broken, it indicates that the product may have been accessed or compromised, which could affect its safety and effectiveness.

For proper storage, keep the product in a cool, dry place to maintain its quality. Always handle it with care to avoid any damage, and follow any specific disposal instructions provided to ensure safety.

Additional Information

You can apply this medication topically, which means you will put it directly on your skin. You can use it up to three times a day or as your doctor advises. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

FAQ

What is maple organics used for?

Maple organics is a cough and cold relief vapor rub that temporarily relieves cough associated with the common cold.

How should I use maple organics?

Rub it on your throat, chest, and/or the bottom of your feet, massaging into the skin until it vanishes. You can use it up to 3 times daily or as directed by a doctor.

Are there any precautions I should take when using this product?

Yes, do not use it by mouth or in your nostrils, and avoid heating, microwaving, or adding it to hot water, as this may cause burns.

What should I do if my cough persists?

Stop using the product and ask a doctor if your cough lasts more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache.

Is it safe to use maple organics during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this product.

What should I do if the product is swallowed?

Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Are there any known side effects?

The product is for external use only, and you should stop using it and consult a doctor if you experience any adverse effects.

Packaging Info

Below are the non-prescription pack sizes of Cough and Cold Therapy (camphor, menthol, eucalyptus oil). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cough and Cold Therapy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Maple Organics Cough & Cold Relief is a soothing and calming cough relief vapor rub. The product is presented in a net weight of 2 ounces (56 grams).

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold.

Dosage and Administration

For adults, the recommended application involves rubbing the solution onto the throat, chest, and/or the bottom of the feet. The solution should be massaged into the skin until it is fully absorbed and no longer visible. If desired, the treated areas may be covered with a warm, dry cloth to enhance the effect. It is advisable to ensure that clothing around the throat and chest is loose to facilitate the inhalation of vapors.

The solution may be applied up to three times daily or as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated for oral administration and intranasal application. Additionally, it should not be subjected to heating, microwaving, or added to hot water or any container that may involve heating water, as these actions may lead to splattering and potential burns.

Warnings and Precautions

For external use only. This product is contraindicated for oral ingestion and should not be applied in the nostrils.

Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

During the application of this product, it is imperative to avoid heating, microwaving, or adding it to hot water or any container that may contain heated water. Such actions may lead to splattering, which poses a risk of burns.

Patients should be instructed to discontinue use and seek medical advice if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

It is essential to keep this and all medications out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be ingested or applied in the nostrils. Caution is advised for individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, particularly if the cough is accompanied by excessive phlegm (mucus).

During the use of this product, patients should avoid heating, microwaving, or adding it to hot water or any container where heating water may occur, as this can lead to splattering and potential burns.

Patients are advised to discontinue use and consult a healthcare professional if they experience a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Additionally, this product should be kept out of reach of children; if swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Cough and Cold Therapy (camphor, menthol, eucalyptus oil). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cough and Cold Therapy.
Details

Pediatric Use

Pediatric patients should be advised to keep this and all medications out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is essential.

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 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; however, it is crucial to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage should be guided by the severity of symptoms and the specific circumstances surrounding the incident. Healthcare providers are encouraged to follow established protocols for the treatment of overdosage, which may include supportive care and symptomatic treatment as necessary.

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.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a tamper-evident container, and it is essential to verify that the seal is intact prior to use. Proper storage conditions must be maintained to ensure product integrity. It is recommended to store the product at controlled room temperature, away from direct sunlight and moisture. Special handling precautions should be observed to prevent damage to the container and to maintain the product's efficacy.

Additional Clinical Information

The product is administered topically and may be used up to three times daily or as directed by a healthcare professional. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cough and Cold Therapy, 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 Cough and Cold Therapy, 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.

Learn more in our Editorial Policy

Last AI update:

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.