Walgreens Cold Pain Relief

Description

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

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. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Bandaging the area after application is not advised, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes or 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. Additionally, it is important to refrain from applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use and avoid using the product with heating pads or devices. Proper storage in a cool, dry place is essential to maintain product integrity.

Patients should be instructed 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.

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 and is flammable; therefore, it should be kept away from excessive heat or open flame. Prior to use, individuals with sensitive skin are advised to consult a doctor.

During the application of this product, it is crucial to avoid contact with the eyes or 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 should be avoided, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended, and hands should be washed with cool water following 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 instructed 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. Pregnant or breastfeeding individuals should seek advice from a health professional before using this product. It is important to keep the product out of reach of children; in the event of accidental ingestion, medical help should be sought or a Poison Control Center contacted immediately.

Drug Interactions

Co-administration of this product with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this product is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring are required in this regard.

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 under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to apply a thin film over the affected areas up to four times daily. Massage of the application site is not necessary.

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.

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 currently no available data on the excretion of this drug in human 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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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 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 seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. Patients should be informed that if their condition worsens, or if symptoms 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 be cautioned against using the product in conjunction with other ointments, creams, sprays, or liniments, as well as on irritated skin or if excessive irritation develops. Additionally, patients should be advised not to bandage the area after application.

Patients should wash their hands thoroughly with cool water after using the product. They should also be informed not to use the product with a heating pad or any heating device. Finally, it is essential to recommend that patients store the product in a cool, dry place and to be aware of its potential effects on sensitive skin.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness.

Due to its flammable nature, it must be kept away from excessive heat sources and open flames to prevent any hazardous situations. Proper storage conditions are crucial for ensuring the safety and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin film over affected areas for adults and children aged 2 years and older, not exceeding four times daily. For children under 2 years of age, consultation with a physician is advised.

Clinicians should counsel patients on important safety information, including that the product is for external use only and is flammable, necessitating avoidance of excessive heat or open flames. Patients should be advised to consult a doctor if they have sensitive skin, and to avoid contact with eyes, mucous membranes, wounds, or damaged skin. It is also important to instruct patients not to use the product with other topical treatments, on irritated skin, or to bandage the area after application. Patients should wash their hands with cool water post-application and refrain from using heating pads or devices. Storage should be in a cool, dry place, and patients should discontinue use and seek medical advice if their condition worsens, persists beyond 7 days, or if symptoms clear and recur. Pregnant or breastfeeding individuals should consult a health professional before use, and the product should be kept out of reach of children, with immediate medical assistance sought in case of accidental ingestion.

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)