Flo Pms Complete

Description

O Positiv-489 is a pharmaceutical compound identified by its unique chemical properties. The specific molecular weight and chemical formula are not provided in the extracted data. The drug is formulated in a dosage form suitable for its intended therapeutic use. Further details regarding its appearance and inactive ingredients are not specified.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including bloating, headache, muscle aches, cramps, backache, fatigue, and water-weight gain.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets orally with water. This dosage may be repeated every 6 hours as needed, with a maximum limit of 6 caplets per day. For children under 12 years of age, it is advised to consult a physician before administration. It is essential to adhere to the recommended dosage and not exceed the specified limits.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that contain acetaminophen concurrently, and to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should discontinue use immediately and seek medical assistance.

This product should not be used by individuals who have a known allergy to acetaminophen or any of its components, nor should it be combined with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to consult a healthcare provider.

Prior to use, patients should consult a healthcare professional if they have any of the following conditions: difficulty urinating due to prostate enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

While using this product, patients may experience excitability, particularly in children, and should exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients are also advised to limit caffeine intake from medications, foods, or beverages, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee, and patients should avoid alcoholic beverages during treatment.

Patients should discontinue use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

In the event of an accidental overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they have a history of allergic reactions to acetaminophen or any of its ingredients, or if they are taking any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

Before using this product, patients should consult a healthcare professional if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use.

While using this product, patients may experience excitability, particularly in children. Caution is advised when driving or operating machinery, as drowsiness may occur. The use of alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee, and patients should avoid alcoholic beverages during use.

Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or persists beyond 10 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition.

For pregnant or breastfeeding patients, it is recommended to consult a healthcare professional before use.

Drug Interactions

The concomitant use of certain medications may lead to significant interactions that require careful consideration.

Anticoagulants The use of warfarin, a blood-thinning agent, may elevate the risk of bleeding when taken concurrently with this product. Monitoring of coagulation parameters is advised to ensure safe therapeutic levels.

CNS Depressants Co-administration of sedatives or tranquilizers can enhance drowsiness. This effect may be further exacerbated by the intake of alcohol, which also contributes to increased sedation. Caution is recommended when engaging in activities that require alertness, such as driving or operating machinery.

Caffeine-containing Products It is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring for these effects is recommended to maintain patient comfort and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Flo Pms Complete (acetaminophen, caffeine, pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. When using this product, excitability may occur, particularly in children. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. For patients aged 12 years and older, the recommended dosage is 2 caplets taken with water every 6 hours as needed, with a maximum of 6 caplets per day.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this product, as the prescribing information does not provide recommendations tailored to this population. Furthermore, there are no particular safety concerns or special precautions noted for geriatric patients. Additionally, the insert does not outline any age-specific considerations for the use of this product in elderly individuals. Healthcare providers should continue to monitor the overall health status of geriatric patients and exercise clinical judgment when prescribing this medication.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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 regarding 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on therapy.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The absence of symptoms does not preclude the possibility of serious adverse effects, and timely medical evaluation is essential to ensure patient safety and appropriate 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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment.

In the event of an accidental overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate potential health risks associated with overdose situations.

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals are advised not to use the product if the outer package is opened or if the blister is torn or broken. The expiration date and lot number can be found on the end flap of the packaging.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F). However, excursions are permitted within a range of 15° to 30°C (59° to 86°F). Proper handling and storage are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Flo Pms Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)