Walgreens Cold Pain Relief

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as arthritis, backache, strains, 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, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or if excessive irritation develops, to prevent exacerbation of the condition. Bandaging the area after application is contraindicated, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may increase the risk of adverse reactions.

Warnings and Precautions

For external use only.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin. During application, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation occurs, the product should be discontinued. Bandaging the area after application is not recommended. Patients should wash their hands thoroughly with cool water following use and should refrain from using the product in conjunction with heating pads or devices. Proper storage in a cool, dry place is essential to maintain product integrity.

Patients should be instructed to stop use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to consult a doctor prior to use if the patient has sensitive skin. During application, patients must avoid contact with the eyes or mucous membranes and should not apply the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and patients should wash their hands with cool water after use. Additionally, the product should not be used with heating pads or devices, and it should be stored in a cool, dry place.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to increased risk of adverse effects or reduced efficacy of the treatment.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The combination may enhance local heat and increase the risk of skin irritation or other adverse reactions.

Healthcare professionals should ensure that patients are advised against these combinations to maintain the safety and effectiveness of the treatment regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreens Cold Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the medication over affected areas up to four times daily, with no need for massage. For pediatric patients under 2 years of age, consultation with a physician is recommended prior to use.

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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. Patients should be informed to monitor their condition closely; if symptoms worsen, persist for more than 7 days, or if symptoms clear up and then recur, they should consult their healthcare provider.

It is important to instruct patients to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin. Patients should not use the product in conjunction with other ointments, creams, sprays, or liniments, and they should avoid application to irritated skin or if excessive irritation develops. Additionally, patients should be advised against bandaging the area after application.

Patients should wash their hands thoroughly with cool water after using the product. They should also be cautioned not to use the product with a heating pad or any heating device. Proper storage is essential; patients should keep the product in a cool, dry place. Lastly, healthcare providers should recommend that patients consult a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in a package configuration that includes specific NDC numbers. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial for ensuring the product remains within its specified quality parameters.

Additional Clinical Information

Patients aged 2 years and older are advised to apply a thin film of the product to affected areas no more than four times daily, without the need for massage. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only; individuals with sensitive skin should consult a doctor before use; and care should be taken to avoid contact with eyes and mucous membranes. It should not be applied to wounds, damaged, or irritated skin, nor used in conjunction with other topical products. Patients should wash their hands with cool water after application and avoid using heating pads or devices. If symptoms worsen, persist beyond 7 days, or recur after improvement, patients should discontinue use and consult a doctor. Pregnant or breastfeeding individuals should seek advice from a health professional before use. Additionally, the product should be kept out of reach of children, and in case of accidental ingestion, medical help or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)