PO Sum on Medicated

Description

PO SUM ON MEDICATED OIL is an external analgesic formulated for topical application. It is available in two presentations: one with a net weight of 1 fluid ounce (30 mL) under NDC 54155-052-01, and a free sample version with a volume of 0.19 fluid ounces (5.6 mL) under NDC 54155-052-02, which is not for resale.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, 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, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily.

In children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate guidance.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or damaged skin due to the potential for exacerbating injury or delaying healing. Additionally, if excessive irritation develops during use, the product should be discontinued immediately to prevent further skin damage or adverse reactions.

Warnings and Precautions

For external use only. It is imperative that this product is applied solely to the skin and not ingested.

General precautions must be observed to ensure safety. This product should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct 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, or when using the product for arthritis-related pain if the pain continues for more than 10 days, if redness is observed, or if the product is being used in children under 12 years of age.

Side Effects

For external use only. Patients should 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, or if using the product for arthritis pain and the pain persists for more than 10 days, redness is present, or if the product is being used in children under 12 years of age.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of PO Sum on Medicated (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this product; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

In pediatric patients under 12 years of age, it is important to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if the product is used for arthritis pain that persists for more than 10 days or is accompanied by redness.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this drug in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

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

There is currently no information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely and manage any symptoms that may arise. In the absence of specific overdosage data, standard supportive care should be implemented as necessary. It is essential to consult local poison control centers or relevant medical authorities for guidance in the event of suspected 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 potential effects in nonclinical settings.

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on wounds or damaged skin. They should also be cautioned against using it if excessive irritation develops. If the condition worsens or if symptoms persist for more than 7 days, patients are encouraged to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, or if pain associated with arthritis persists for more than 10 days, patients should seek medical advice.

Healthcare providers should inform patients to stop use and consult a doctor if any redness is present or if they are treating conditions affecting children under 12 years of age. It is important to remind patients to avoid contact with the eyes while using this product and to refrain from bandaging tightly.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 15°C to 30°C (59°F to 86°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for preserving the quality of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for PO Sum on Medicated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)