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Cvs Cold and Hot Medicated Xl

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 750 mg
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
October 2, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 750 mg
Other brand names
Dosage form
Patch
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 2010
Label revision date
October 2, 2020
Manufacturer
CVS PHARMACY, INC.
Registration number
part348
NDC root
59779-981
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

You may be looking for a medication that is designed to provide relief for certain conditions affecting the skin. While the specific name and details of the drug are not provided, it is typically applied directly to the affected area using a patch. This method allows the medication to work locally where it is needed.

For adults and children over 12 years, the patch is applied to the skin and can be used for up to 8 hours, with a maximum of three applications per day. If you are considering this treatment for a child under 12, it is important to consult a doctor first.

Uses

You can use this medication to help relieve discomfort in specific areas of your body. For adults and children over 12 years old, simply peel off the protective backing and apply the sticky side of the patch directly to the affected area. You can wear the patch for up to 8 hours, but make sure not to use it more than three times a day.

If you have a child under 12 years old, it's important to consult a doctor before using this patch. There are no specific concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects (which are effects that do not cause birth defects) associated with this medication.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to be aware of certain precautions when using this medication. You should never use it on infants, as it is contraindicated for that age group. If you accidentally swallow the medication, seek medical help or contact a Poison Control Center right away.

Additionally, avoid tightly bandaging the area where the medication is applied, and do not use it with a heating pad. Make sure to keep it away from your eyes and mucous membranes, and do not apply it to any wounds or damaged skin. Following these guidelines will help ensure your safety while using this product.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if you notice any redness, or if you develop skin irritation. Additionally, if your symptoms persist for more than seven days or improve only to return within a few days, it's important to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. It's important to keep it out of reach of children and not to use it on infants. If the product is swallowed, seek medical help or contact a Poison Control Center right away.

You should stop using this product and consult your doctor if your condition worsens, if you notice any redness or skin irritation, or if your symptoms last more than 7 days or return shortly after improving. Your health and safety are important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 out of reach of children and to avoid using it on infants. If your child is under 12 years old, you should consult a doctor before using this medication. This ensures that you get the right guidance and care for your child's specific needs. Always prioritize safety when it comes to medications for young ones.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

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, 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 performance of your product, store it at room temperature, keeping it below 86°F (30°C). This helps maintain its effectiveness and safety.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You should apply this medication topically, using it for up to 8 hours and no more than 3 times a day. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Keep it out of reach of children and do not use it on infants. If the medication is swallowed, seek medical help or contact a Poison Control Center right away.

FAQ

How should I use this drug if I am an adult or a child over 12 years old?

Peel off the protective backing and apply the sticky side to the affected area. You can use it for up to 8 hours and no more than 3 times a day.

What should I do if I am using this drug for a child under 12 years old?

You should consult a doctor before use.

Are there any contraindications for this drug?

Do not use this drug on infants.

What should I do if I accidentally swallow this drug?

Get medical help or contact a Poison Control Center immediately.

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

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

What precautions should I take while using this drug?

Keep it out of reach of children, avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if my condition worsens or if I experience skin irritation?

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

How should I store this drug?

Store at room temperature, not to exceed 86°F (30°C).

Packaging Info

Below are the non-prescription pack sizes of Cvs Cold and Hot Medicated Xl (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Cold and Hot Medicated Xl.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the topical treatment of localized pain in adults and children over 12 years of age. The application involves peeling off the protective backing and adhering the sticky side of the patch to the affected area. Each patch should be used for a maximum duration of 8 hours and may be applied no more than 3 times a day.

For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

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

Dosage and Administration

No dosage and administration information is available in the provided text.

Contraindications

Use is contraindicated in infants.

Due to the risk of serious adverse effects, the product should not be swallowed; in such an event, seek medical assistance or contact a Poison Control Center immediately.

Additionally, avoid tight bandaging or the use of heating pads in conjunction with this product. Contact with eyes and mucous membranes must be avoided to prevent irritation. The application of this product to wounds or damaged skin is also contraindicated.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children and is not used on infants. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness appears, skin irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if redness is present, if skin irritation develops, or if symptoms persist for more than 7 days or clear up and then occur again within a few days.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Cold and Hot Medicated Xl (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Cold and Hot Medicated Xl.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children, and the product is not recommended for use in infants. For children under 12 years of age, it is advised to consult a healthcare professional prior to use.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used on infants. In the event of accidental swallowing, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness appears, skin irritation develops, or if symptoms persist for more than 7 days or clear up and then recur within a few days.

When using this product, patients must be reminded to use it only as directed. They should avoid bandaging the area tightly or using it in conjunction with a heating pad. Additionally, patients should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin.

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, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and should be applied for a maximum duration of 8 hours, not exceeding three applications per day. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the product out of reach of children and to avoid use on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Cvs Cold and Hot Medicated Xl, 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 Cvs Cold and Hot Medicated Xl, 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.