Meijer Extra Strength Cold and Hot Medicated

Description

The product is identified by SPL code 34089-3 and is formulated as a topical analgesic patch. Each patch contains 3.5% menthol as the active ingredient. The patches are rectangular, measuring 10 cm x 14 cm, and are characterized by a white color and a smooth surface. Inactive ingredients include acrylic adhesive, polyethylene, non-woven fabric, water, glycerin, propylene glycol, sodium hydroxide, citric acid, and fragrance.

Uses and Indications

This drug is indicated for the relief of symptoms in adults and children aged 12 years and older. It is recommended for use for a duration of up to 8 hours and should not be administered more than 3 times a day. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects.

Contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury.

Application to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center or a healthcare professional.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if there is any presence of redness, or if skin irritation develops. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

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

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the product is applied by peeling off the protective backing and adhering the sticky side to the affected area. It is indicated for use for up to 8 hours and should not be applied more than three times a day.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information available 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. 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 the safety of both the mother and the developing fetus or nursing infant.

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical assistance or contact a Poison Control Center immediately.

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

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. It is also important to instruct patients to avoid contact with the eyes and mucous membranes, and to refrain from applying 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 healthcare professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)