Cvs Cold and Hot

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "B" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and iron oxide (red and yellow).

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. However, the precise indications and usage have not been explicitly stated in the provided information.

Healthcare professionals are advised to consider the absence of information regarding teratogenic and nonteratogenic effects when prescribing this medication. Further clinical evaluation and consultation of relevant guidelines are recommended to ensure appropriate use in targeted patient populations.

Dosage and Administration

The product is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895, and is manufactured in China.

Currently, there is no specific information available regarding the route, method, or frequency of administration for this product. Healthcare professionals are advised to consult relevant clinical guidelines or product literature for further details on administration techniques and dosing recommendations.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, the application of the product in conjunction with a heating pad is contraindicated, as this may lead to excessive heat and increase the risk of adverse effects. Furthermore, the product should not be used in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. This product is not intended for internal use and should be applied solely to the skin as directed.

General precautions must be observed to ensure safe use. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, it is contraindicated to use this product in conjunction with a heating pad, as this may increase the risk of skin irritation or burns. Special caution is advised when considering use in pediatric patients; this product should not be applied to children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops. These actions are critical to prevent potential complications and ensure patient safety.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay to receive appropriate guidance and intervention.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

Before using this product, patients are encouraged to ask a doctor if they have redness over the affected area, as this may indicate a more serious condition that requires professional evaluation.

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 Cvs Cold and Hot (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents aged 12 years and older, the medication should not be applied for more than 8 hours at a time and may be applied to the affected area no more than 3 times daily.

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. It is advisable to monitor these patients closely for any 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 prescribing 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, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific overdosage data.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to caution patients against using the product on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should instruct patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

When discussing the use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be reminded to avoid contact with eyes or mucous membranes and not to bandage the area tightly. It is also crucial to inform patients to discontinue use at least 1 hour before taking a bath or shower and to avoid using the product immediately after bathing.

Finally, healthcare providers should recommend that patients consult a doctor before using the product if there is any redness over the affected area.

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, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should not be worn for more than 8 hours and may be applied to the affected area no more than three times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)