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Pamabrom
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- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Capsule, Liquid Filled
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- January 27, 2026
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Capsule, Liquid Filled
- 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 2024
- Label revision date
- January 27, 2026
- Manufacturer
- Softgel Healthcare Pvt Ltd
- Registration number
- M027
- NDC root
- 35916-1654
- Drug Information (PDF)
- Prescribing information, PDF file
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Drug Overview
Pamabrom is a medication designed to help relieve temporary water weight gain, bloating, swelling, and the feeling of fullness that can occur during the premenstrual and menstrual periods. It is often used by individuals seeking comfort from these common symptoms associated with their menstrual cycle.
Uses
If you're experiencing temporary water weight gain, bloating, or swelling, this medication can help provide relief. Many people also find it useful for alleviating the full feeling that often accompanies premenstrual and menstrual periods.
It's important to note that this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer option for those who may be concerned about such risks.
Dosage and Administration
You should take one softgel capsule after breakfast, along with a full glass of water. If you need more relief, you can take another capsule after 6 hours, but make sure not to exceed four softgel capsules in a single day. It’s best to start taking the capsules 5 or 6 days before your period begins and continue until you feel the relief you want or until your period ends.
To stay hydrated, aim to drink 6 to 8 glasses of water each day. This medication is intended for normally healthy adults only, and if you are under 18 years old, you should only use it if directed by a doctor.
What to Avoid
It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms persist for more than ten consecutive days. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.
Side Effects
You can feel reassured that there are no known side effects associated with this medication. There are no warnings, adverse reactions, or serious side effects reported, which means it is generally considered safe for use. If you have any concerns or experience unusual symptoms while taking this medication, it's always a good idea to consult with your healthcare provider.
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 you avoid any potential interactions.
If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, if your symptoms persist for more than ten consecutive days, stop taking the medication and reach out to your doctor for further guidance.
Overdose
It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.
In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.
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 use it only as directed by a doctor. This ensures that the treatment is safe and appropriate for their age and health needs. Always consult with a healthcare professional before giving any medication to your child to ensure their well-being.
Geriatric Use
When it comes to using Pamabrom, there are no specific recommendations or considerations for older adults mentioned in the drug insert. This means that, generally, the same guidelines apply to you as they do to younger adults. However, it's always important to consult with your healthcare provider before starting any new medication, especially if you have other health conditions or are taking multiple medications.
As you age, your body may process medications differently, so your doctor may want to monitor your response to Pamabrom closely. If you have any concerns or experience unusual side effects, be sure to discuss them with your healthcare professional.
Renal Impairment
If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment.
If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, you should consider using a lower dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.
Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.
Storage and Handling
To ensure the best quality and safety of your product, store the blue transparent, oval-shaped softgel capsules in a cool, dry place. These capsules contain a clear to pale blue liquid and are packaged in a bottle that features a safety seal under the cap. It’s important to check that this seal is intact before use; do not use the product if the seal appears broken, as this could indicate contamination or that the product has been tampered with.
When handling the capsules, make sure your hands are clean to maintain a sterile environment (a clean area free from germs). Always follow any additional instructions provided with the product for safe usage and disposal.
Additional Information
You should take one softgel capsule after breakfast with a full glass of water. If needed, you can repeat the dose after 6 hours, but do not exceed four softgel capsules in a day. It's best to start taking the capsules 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 if you are taking any other medications. If your symptoms persist for more than ten consecutive days, stop using the product 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 Pamabrom used for?
Pamabrom is used for the relief of temporary water weight gain, bloating, swelling, and the full feeling associated with premenstrual and menstrual periods.
How should I take Pamabrom?
You should take one softgel capsule after breakfast with a full glass of water. The dose may be repeated after 6 hours, not to exceed four softgel capsules per day.
When should I start taking Pamabrom?
Start taking Pamabrom 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 age restrictions for using Pamabrom?
Pamabrom is for use by normally healthy adults only. Persons under 18 years of age should use it only as directed by a doctor.
What should I do if my symptoms last more than ten days?
You should stop using Pamabrom and ask a doctor if your symptoms last for more than ten consecutive days.
Can I take Pamabrom if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using Pamabrom.
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 there any specific information for patients with kidney problems?
Yes, dosage adjustments may be necessary for patients with reduced renal function, and renal function tests should be monitored regularly.
What should I do if I am taking other medications?
You should ask a doctor or pharmacist before using Pamabrom if you are taking any other medication.
Packaging Info
Below are the non-prescription pack sizes of Pamabrom. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Capsule, Liquid Filled | 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 Pamabrom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No description information is available for the specified drug.
Uses and Indications
This drug is indicated for the relief of temporary water weight gain, bloating, swelling, and the full feeling associated with the 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) softgel capsule 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) softgel capsules per day. It is recommended to initiate dosing 5 to 6 days prior to the expected onset of menstruation and to continue until either the desired relief is achieved or the menstrual period concludes.
In addition, it is important for patients to maintain adequate hydration by consuming 6 to 8 glasses of water daily. This product is intended for use by normally healthy adults only. Individuals under 18 years of age should use this medication only as directed by a healthcare professional.
Contraindications
There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than ten consecutive days.
Warnings and Precautions
Patients should 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 avoid potential drug interactions that may compromise patient safety or treatment efficacy.
In the event of an overdose, it is critical to seek emergency medical assistance immediately or contact a Poison Control Center. Prompt action is necessary to mitigate any adverse effects associated with overdose.
Patients are advised to discontinue use and consult their healthcare provider if symptoms persist for more than ten consecutive days. This recommendation is important to ensure that any underlying conditions are appropriately evaluated and managed.
Side Effects
There are no reported adverse reactions associated with the use of this product. Clinical trials and postmarketing experiences have not identified any common, less common, rare, or serious adverse reactions, nor have any allergic reactions or specific side effects in the cardiovascular, neurological, or dermatologic categories been documented. As such, healthcare professionals should be aware that the safety profile remains unremarkable based on the available data.
Drug Interactions
There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Pamabrom. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Capsule, Liquid Filled | 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 may not require specific dosage adjustments or considerations when using Pamabrom, as the prescribing information does not provide any recommendations tailored to this population. However, healthcare providers should remain vigilant in monitoring for potential adverse effects, as geriatric patients may have altered pharmacokinetics and increased sensitivity to medications. It is advisable to assess the overall health status and concurrent medications of elderly patients to ensure safe and effective use of Pamabrom.
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 should consider individual circumstances and the specific health needs of the patient when making recommendations.
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 human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.
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 recommended for individuals with compromised liver function. It is advisable for healthcare providers to exercise caution and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, given the lack of specific data.
Overdosage
There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and adhere to standard protocols for managing potential overdose situations.
In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation.
Healthcare professionals are encouraged to report any cases of suspected overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.
Nonclinical Toxicology
No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.
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 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.
Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if symptoms persist for more than ten consecutive days. This guidance is essential to ensure that patients receive appropriate care and to prevent potential complications.
Storage and Handling
The product is supplied in the form of blue transparent, oval-shaped softgel capsules that contain a clear to pale blue liquid. These capsules are packaged in a bottle equipped with a safety seal under the cap. It is imperative that the product not be used if the safety seal appears broken, as this indicates potential tampering or contamination.
For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and moisture. It is recommended to maintain a temperature range that ensures the integrity of the capsules and their contents. Special handling precautions should be observed to prevent damage to the capsules and to ensure the safety and efficacy of the product.
Additional Clinical Information
Patients should take one softgel capsule after breakfast with a full glass of water. The dose may be repeated after 6 hours, but should not exceed four softgel capsules per day. It is recommended to start taking the medication 5 or 6 days before the onset of the period and to continue until desired relief is obtained or the period ends.
Clinicians should advise patients to consult a doctor or pharmacist before use if they are taking any other medications. Patients should discontinue use and seek medical advice if symptoms persist for more than ten consecutive days. Pregnant or breastfeeding patients should consult a healthcare professional prior to use. Additionally, the product should be kept out of reach of children, and in the event of an overdose, medical help or contact with a Poison Control Center should be sought immediately.
Drug Information (PDF)
This file contains official product information for Pamabrom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.