ADD CONDITION
Diurex
Last content change checked dailysee data sync status
- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 1995
- Label revision date
- April 11, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 1995
- Label revision date
- April 11, 2025
- Manufacturer
- Kobayashi Healthcare International, Inc.
- Registration number
- M027
- NDC root
- 52389-249
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
This medication is designed to help relieve temporary water retention, bloating, swelling, and the feeling of fullness that can occur, particularly during the premenstrual and menstrual periods. It works by addressing these uncomfortable symptoms, providing you with some relief during times when you may feel particularly affected by them. If you're experiencing these issues, this medication may be a supportive option for you.
Uses
If you're experiencing temporary water retention, bloating, or swelling, this medication can help provide relief. It is also effective for alleviating the full feeling that often accompanies premenstrual and menstrual periods.
You can use this medication to feel more comfortable during these times, as it targets the discomfort associated with excess fluid in your body.
Dosage and Administration
When you need relief from menstrual discomfort, take one pill after breakfast with a full glass of water. If you find that you need more relief, you can take another pill after 6 hours, but be sure not to exceed four pills in a 24-hour period.
For the best results, start taking the medication 5 or 6 days before your period begins and continue until you feel the relief you want or until your period ends. This way, you can manage your symptoms effectively throughout your cycle.
What to Avoid
It's important to keep this medication out of reach of children to ensure their safety. If you find that your symptoms persist for more than ten consecutive days, you should stop using the medication and consult your doctor for further guidance. This will help ensure that you receive the appropriate care and support for your health needs.
Side Effects
If you experience any symptoms that persist for more than ten consecutive days while using this medication, it’s important to stop using it and consult your doctor. Additionally, before starting this medication, make sure to talk to your doctor or pharmacist if you are currently taking any other medications, as there may be interactions to consider.
Warnings and Precautions
Before using this medication, it’s important to consult with your doctor or pharmacist, especially if you are taking any other medications. This will help ensure that there are no harmful interactions.
If your symptoms persist for more than ten consecutive days, you should stop taking the medication and reach out to your doctor for further guidance. Additionally, in the event of an overdose, seek emergency medical help immediately or contact a poison control center. Your safety is a priority, so don’t hesitate to get the help you need.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.
In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
If you are considering this medication for a child under 18 years old, it is important to ensure that it is used only as directed by a doctor. This means you should consult with a healthcare professional to determine the appropriate dosage and any specific guidelines for your child's age and health condition. Always follow their recommendations closely to ensure your child's safety and well-being.
Geriatric Use
It's important to note that this medication is intended for normally healthy adults. If you are caring for an older adult, be aware that they should only use this medication if it has been specifically directed by a healthcare provider. Additionally, individuals under 18 years of age should also use this medication only as prescribed by a doctor. Always consult with a healthcare professional to ensure safety and proper use, especially for older adults who may have unique health considerations.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.
Hepatic Impairment
If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.
Drug Interactions
It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking any other medications. This is because different drugs can interact with each other, potentially affecting how well they work or increasing the risk of side effects.
By discussing your current medications, you can help ensure your treatment is safe and effective. Always prioritize open communication with your healthcare provider to avoid any unexpected complications.
Storage and Handling
To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed to prevent contamination. Before using, check that the seal is intact and that the contents match the product description; if either of these conditions is not met, do not use the product. Once opened, please remember to discard any remaining contents to maintain safety and effectiveness.
Additional Information
You should take one pill after breakfast with a full glass of water. If needed, you can repeat the dose after 6 hours, but do not take more than four pills in a 24-hour period. It's best to start taking the medication 5 or 6 days before your period begins and continue until you feel relief or until your period ends.
Before using this medication, consult with your doctor or pharmacist, especially if you are taking other medications. If your symptoms persist for more than ten consecutive days, stop using it and seek medical advice. If you are pregnant or breastfeeding, check with a healthcare professional before use. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a poison control center immediately.
FAQ
What is this drug used for?
This drug is used for the relief of temporary water retention, bloating, swelling, and the full feeling associated with the premenstrual and menstrual periods.
How should I take this medication?
You should take one pill after breakfast with a full glass of water. The dose may be repeated after 6 hours, not to exceed four pills in 24 hours.
When should I start taking this medication?
Start taking the medication 5 or 6 days before the onset of your period and continue until you obtain the desired relief or until the end of your period.
Are there any warnings I should be aware of?
Yes, stop use and ask a doctor if symptoms last more than ten consecutive days. Also, ask a doctor or pharmacist before use if you are taking any other medications.
What should I do in case of an overdose?
In case of overdose, get medical help or contact a poison control center right away.
Is this medication safe for children?
Persons under 18 years of age should use this medication only as directed by a doctor.
What should I do if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before use.
How should I store this medication?
Store at room temperature, protect from light, and keep the container tightly closed. Do not use if the seal appears broken.
Packaging Info
Below are the non-prescription pack sizes of Diurex (pamabrom). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Diurex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.
Uses and Indications
This drug is indicated for the relief of temporary water retention, bloating, and swelling. It is also indicated for the alleviation of the full feeling associated with premenstrual and menstrual periods.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Adults are advised to take one (1) pill after breakfast, accompanied by a full glass of water. The dose may be repeated after an interval of 6 hours, with a maximum limit of four (4) pills within a 24-hour period. It is recommended to initiate dosing 5 to 6 days prior to the expected onset of menstruation and to continue administration until the desired relief is achieved or until the conclusion of the menstrual period.
Contraindications
There are no specific contraindications identified for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion. Additionally, if symptoms persist for more than ten consecutive days, discontinue use and consult a healthcare professional.
Warnings and Precautions
Patients should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any other medications. This precaution is essential to avoid potential drug interactions that may compromise treatment efficacy or safety.
In the event that symptoms persist for more than ten consecutive days, it is imperative to discontinue use and seek medical advice. Prolonged symptoms may indicate an underlying condition that requires further evaluation and management.
In cases of suspected overdose, immediate medical assistance should be sought. Patients or caregivers are advised to contact a poison control center or seek emergency medical help without delay to ensure appropriate intervention and care.
Side Effects
Patients should be advised to stop use and consult a doctor if symptoms persist for more than ten consecutive days. This warning is crucial to ensure that any underlying conditions are appropriately evaluated and managed.
Additionally, it is recommended that patients ask a doctor or pharmacist before using this product if they are currently taking any other medications. This precaution helps to prevent potential drug interactions and ensures safe use of the product in conjunction with other therapies.
Drug Interactions
Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any other medications. This precaution is essential to identify potential drug interactions that may affect the efficacy or safety of treatment.
It is important to monitor for any adverse effects or changes in therapeutic outcomes when combining this medication with others. Adjustments to dosage or additional monitoring may be necessary based on the specific interactions identified during consultation.
Packaging & NDC
Below are the non-prescription pack sizes of Diurex (pamabrom). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 50 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 18 years of age should use this medication only as directed by a healthcare professional. It is essential to follow the prescribed guidelines to ensure safety and efficacy in this population.
Geriatric Use
Elderly patients are defined as individuals aged 65 years and older. The medication is intended for use by normally healthy adults only, and there are no specific dosage adjustments recommended for geriatric patients. However, it is essential to consider that elderly patients may have different physiological responses to medications, which could necessitate careful monitoring for safety and efficacy.
Additionally, this medication is not indicated for individuals under 18 years of age unless directed by a healthcare provider. Therefore, healthcare professionals should exercise caution when prescribing this medication to elderly patients, ensuring that they are appropriately assessed for overall health status and any potential contraindications. Regular monitoring may be warranted to mitigate risks associated with age-related changes in pharmacokinetics and pharmacodynamics.
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 considered in these populations to ensure the safety of both the mother and the fetus or 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 medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.
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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.
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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.
If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.
Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment 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
Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated phone number provided under the Questions? section.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a poison control center immediately.
Patients should be informed to discontinue use and consult a doctor if symptoms persist for more than ten consecutive days. Additionally, it is important for healthcare providers to recommend that patients consult with a doctor or pharmacist before using this medication if they are currently taking any other medications, to avoid potential interactions.
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 room temperature, away from direct light exposure to protect its quality. Users are advised to inspect the seal before use; the product should not be utilized if the seal appears broken or if the contents do not match the product description. Additionally, any unused product should be discarded after opening to ensure safety and efficacy.
Additional Clinical Information
Patients should take one pill after breakfast with a full glass of water. The dose may be repeated after 6 hours, with a maximum of four pills in a 24-hour period. It is recommended to start taking the medication 5 or 6 days before the expected onset of menstruation and to continue until desired relief is achieved or the period ends.
Clinicians should advise patients to consult a doctor or pharmacist before use if they are taking other medications. Patients should discontinue use and seek medical advice if symptoms persist for more than ten consecutive days. Pregnant or breastfeeding individuals should also consult a healthcare professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, medical assistance or contact with a poison control center should be sought immediately.
Drug Information (PDF)
This file contains official product information for Diurex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.