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Herbalgy

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 10 mL/100 mL
  • Menthol 16 mL/100 mL
  • Methyl Salicylate 31.5 mL/100 mL
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
February 27, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 10 mL/100 mL
  • Menthol 16 mL/100 mL
  • Methyl Salicylate 31.5 mL/100 mL
Other brand names
Dosage form
Oil
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 2012
Label revision date
February 27, 2012
Manufacturer
Wicsun Trading
Registration number
part348
NDC root
66897-003
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 minor aches and pains in muscles and joints. It can be particularly helpful for discomfort associated with simple backaches, strains, bruises, and sprains. If you're experiencing these types of pain, this drug may offer you some comfort and support in managing your symptoms.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for discomfort associated with simple backaches, strains, bruises, and sprains. If you're dealing with any of these common issues, this medication may help ease your pain and improve your comfort.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. Do not apply it on wounds, irritated, or damaged skin, and always follow the directions provided. While using the product, make sure to avoid contact with your eyes, mouth, or any mucous membranes, and refrain from bandaging the area tightly.

By adhering to these guidelines, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, please consult a healthcare professional for further advice.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, if you experience excessive skin irritation, it's important to seek medical advice.

If you are using this product for arthritis, please discontinue use and contact a healthcare professional if your pain continues for more than 10 days, if you notice any redness, or if the product is being used on children under 12 years of age.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that are not intended. It's important to keep this product out of reach of children to prevent accidental poisoning. If a child swallows it, contact a doctor or the Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days. Additionally, if you experience excessive skin irritation or if you are using it for arthritis and your pain persists for more than 10 days, or if you notice redness, you should also reach out to your doctor. If the product is being used on children under 12 years of age, consult a doctor as well.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this product. They can provide personalized advice and help you understand any potential risks or considerations related to your specific situation. Your health and the health of your baby are paramount, so always seek guidance when it comes to medication use during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this product. They can provide personalized advice and ensure that it is safe for you and your baby. Taking this precaution helps protect your health and supports your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day.

Additionally, if your child is under 12 years old and has any specific health conditions, it's best to talk to a doctor before using this medication. Always prioritize your child's safety and well-being by seeking professional advice when needed.

Geriatric Use

While there is no specific information about how this medication should be used by 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 concerns with your healthcare provider. They can help determine the best approach 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 check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on 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 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 specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, no more than 3-4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this product without consulting a doctor first.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children to prevent accidental poisoning. If the product is swallowed, contact a doctor or Poison Control Center right away.

FAQ

What is this drug used for?

This drug is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, bruises, and sprains.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. Children under 2 years of age should not use it and should consult a doctor.

How should I apply this drug?

You should apply it to the affected area not more than 3-4 times daily.

Are there any warnings for this drug?

Yes, it is for external use only. Avoid contact with eyes, mouth, or mucous membranes, and do not bandage tightly.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if excessive skin irritation develops.

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

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

What should I do if I accidentally swallow this drug?

Keep it out of reach of children to avoid accidental poisoning. If swallowed, contact a doctor or Poison Control Center immediately.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Herbalgy (camphor menthol methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Herbalgy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be applied to wounds, irritated, or damaged skin, and should only be used as directed. Additionally, contact with the eyes, mouth, or mucous membranes should be avoided. Tight bandaging is also not recommended during use.

Warnings and Precautions

FOR EXTERNAL USE ONLY.

It is imperative to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical attention should be sought by contacting a doctor or the Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if excessive skin irritation occurs, the patient should stop using the product and seek medical advice.

For patients using this product for arthritis, it is crucial to monitor the duration and severity of symptoms. If pain persists for more than 10 days, if redness is observed, or if the patient is under 12 years of age, the patient should cease use and consult a healthcare provider.

Side Effects

Patients should be aware that this product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if excessive irritation of the skin develops, it is important to stop using the product and seek medical advice.

For patients using this product for arthritis, it is recommended to stop use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Herbalgy (camphor menthol methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Herbalgy.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 3-4 times daily.

Healthcare professionals are advised to consult with a doctor regarding conditions affecting children under 12 years of age to ensure appropriate management and safety.

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 product. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety and well-being of both the mother and the nursing infant.

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 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 adhere to 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

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

Patients should be informed not to use the product on wounds, irritated, or damaged skin, and to use it only as directed. It is important to counsel patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if excessive skin irritation develops or if they are using the product for arthritis and pain persists for more than 10 days, if redness is present, or if the patient is under 12 years of age.

While using the product, patients should be cautioned to avoid contact with the eyes, mouth, or mucous membranes, and to refrain from bandaging the area tightly.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3-4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding before using the product. It is also crucial to keep the product out of reach of children to prevent accidental poisoning; in the event of ingestion, immediate contact with a doctor or Poison Control Center is necessary. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Herbalgy, 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 Herbalgy, 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.