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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
Herbalgy Pharmaceutical Limited
Registration number
part348
NDC root
66898-100
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 conditions such as simple backaches, strains, bruises, and sprains. If you're experiencing discomfort from these common issues, this product may offer you some relief.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with simple backaches, strains, bruises, and sprains.

You can rely on it to ease those everyday pains, allowing you to get back to your regular activities more comfortably. Remember, it's designed for short-term use to help you feel better when you need it most.

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 and effectively. You should never apply it to wounds, irritated, or damaged skin, as this can lead to complications. Always follow the directions provided; using it in any other way is not recommended.

While using this product, be careful to avoid contact with your eyes, mouth, or any mucous membranes, as this can cause irritation. Additionally, do not bandage the area tightly, as this may affect how the product works. Following these guidelines will help ensure your safety and the best results.

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 or if you are using this product for arthritis and your pain persists for more than 10 days, or if you notice redness, it's important to seek medical advice. This is especially crucial for 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 feel unwell after taking the medication, seek help right away.

In case of an overdose, contact your healthcare provider or local emergency services immediately. They can provide the necessary assistance and guidance. Always remember that it's better to be safe and get checked if you have any concerns 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 you with personalized advice and help ensure the safety of both you and your baby. Always prioritize your health and the health of your child by seeking guidance from a trusted medical expert.

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 help you understand any potential risks or effects on your milk production and your baby. Your health and your baby's well-being are the top priorities, so don’t hesitate to seek guidance.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. 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, avoid using this medication for any conditions in children under 12 years of age, as it may not be safe for them. Always prioritize your child's health and consult a healthcare professional if you have any questions or concerns.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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 can apply this medication to the affected area 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, you should consult a doctor before use.

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 medication is swallowed, contact a doctor or the Poison Control Center right away.

FAQ

What is this product used for?

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

How should I apply this product?

You should apply it to the affected area not more than 3-4 times daily if you are an adult or a child 2 years of age and older.

Can children under 2 years use this product?

No, do not use this product on children under 2 years of age; consult a doctor instead.

Are there any contraindications for using this product?

Yes, do not apply it on wounds, irritated, or damaged skin.

What should I do if my condition worsens?

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

Is this product safe to use during pregnancy or breastfeeding?

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

What precautions should I take while using this product?

Avoid contact with the eyes, mouth, or mucous membranes, and do not bandage tightly.

How should I store this product?

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

What should I do if I accidentally swallow this product?

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

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

The product is identified by SPL Code 34089-3 and is presented as a clear, colorless to pale yellow liquid. It contains an active ingredient derived from herbal extract. The formulation also includes inactive ingredients such as glycerin, water, and natural flavoring.

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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

Application of this product is contraindicated on wounds, irritated, or damaged skin. It should not be used otherwise than as directed. Additionally, contact with the eyes, mouth, or mucous membranes must be avoided. Tight bandaging is also contraindicated during use.

Warnings and Precautions

FOR EXTERNAL USE ONLY.

Healthcare professionals should advise patients 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 Poison Control Center.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. Additionally, if excessive skin irritation develops, or if the product is being used for arthritis and pain persists for more than 10 days, or if redness is observed, medical advice should be sought. Special caution is warranted when administering this product to children under 12 years of age.

Regular monitoring of the patient's condition is recommended to ensure safety and efficacy during treatment.

Side Effects

Patients should be aware that this product is 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, patients should stop using the product and seek medical advice.

For patients using this product specifically for arthritis, it is important to seek medical attention 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

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 and must consult a doctor for guidance. For children aged 2 years and older, the medication may be applied to the affected area no more than 3-4 times daily. It is important to note that this medication is not recommended for use in conditions affecting children under 12 years of age.

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.

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 currently no available data regarding the excretion of this product in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this product during lactation.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to recommended dosing guidelines are crucial to minimize the risk of overdosage and ensure patient safety.

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 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. In the event of ingestion, patients should be instructed to 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 apply it only as directed. They should be counseled 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 they experience excessive skin irritation 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 a child under 12 years of age.

While using this 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 should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3-4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek professional advice 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.

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.