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Pamprin
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- 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 2025
- Label revision date
- December 31, 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 2025
- Label revision date
- December 31, 2025
- Manufacturer
- Focus Consumer Healthcare, LLC
- Registration number
- M027
- NDC root
- 71687-3009
- 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 provide temporary relief from bloating, water-weight gain, swelling, and the feeling of fullness that can occur during the premenstrual and menstrual periods. It aims to help alleviate these uncomfortable symptoms, making your experience during this time more manageable.
Uses
If you're experiencing discomfort from bloating, water-weight gain, swelling, or a full feeling, especially during your premenstrual or menstrual periods, this medication may provide you with temporary relief. It’s designed to help alleviate these common symptoms, making your experience more manageable.
Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can feel more at ease while using it.
Dosage and Administration
When taking this medication, it's important to stick to the recommended dose to ensure your safety. If you are an adult or a child aged 12 years and older, you should take 1 caplet with a glass of water. You can repeat this every 6 hours if needed, but make sure not to take more than 4 caplets in a single day.
If you have a child under 12 years old, it's best to consult a doctor before giving them this medication. This way, you can ensure they receive the appropriate care and dosage for their age. Always follow these guidelines to use the medication safely and effectively.
What to Avoid
You should not use this product if you have ever experienced an allergic reaction to it or any of its ingredients. It's important to prioritize your safety, so please avoid using it under these circumstances. If you have any concerns or questions about your health or this product, consider discussing them with a healthcare professional.
Side Effects
It's important to be aware of potential side effects when considering medication. While the specific side effects are not detailed, you should always consult with your healthcare provider about any concerns or questions you may have regarding your treatment. They can provide you with the most relevant information tailored to your health needs.
If you experience any unusual symptoms or reactions after starting a new medication, it's crucial to seek medical advice promptly. Your health and safety are the top priority, so don't hesitate to reach out for support.
Warnings and Precautions
It's important to be aware of certain precautions when using this medication. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately. This is crucial for your safety.
While there are no specific warnings or general precautions listed, it's always a good idea to stay informed about how any medication may affect you. If you experience any unusual symptoms or have concerns, don't hesitate to reach out to your healthcare provider for 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’s crucial to seek immediate medical help.
In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children 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 have a child under 12 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.
If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.
Renal Impairment
If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially through tests that measure creatinine clearance (a test that estimates how well your kidneys filter waste).
Before starting any new treatment, your renal function should be assessed, and ongoing tests will be necessary to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication. Always communicate with your healthcare provider about your kidney health to ensure the best care.
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 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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.
Storage and Handling
To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to protect the contents from light and maintain their effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle the product safely and effectively.
Additional Information
You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 caplet with water every 6 hours as needed, but do not exceed 4 caplets in a day. If the patient is under 12 years old, it's important to consult a doctor before use.
FAQ
What is the drug used for?
This drug is used for the temporary relief of bloating, water-weight gain, swelling, and a full feeling associated with the premenstrual and menstrual periods.
What should I do if I have an allergic reaction to this product?
Do not use this product if you have ever had an allergic reaction to it or any of its ingredients.
What is the recommended dosage for adults and children 12 years and older?
You should take 1 caplet with water every 6 hours as needed, but do not exceed 4 caplets per day.
What should children under 12 do?
Children under 12 years should consult a doctor before use.
What should I do in case of overdose?
In case of overdose, get medical help or contact a Poison Control Center right away.
Can I take this drug if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before use.
How should I store this drug?
Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.
Are there any special considerations for patients with renal impairment?
Yes, patients with renal impairment may need dosage adjustments and should have their renal function monitored regularly.
Packaging Info
Below are the non-prescription pack sizes of Pamprin (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
| ||||
Drug Information (PDF)
This file contains official product information for Pamprin, 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 temporary relief of bloating, water-weight gain, swelling, and a full feeling associated with the premenstrual and menstrual periods.
There are no teratogenic or nonteratogenic effects reported for this drug.
Dosage and Administration
Adults and children aged 12 years and older are advised to take 1 caplet with water. This dose may be repeated every 6 hours as needed, with a maximum limit of 4 caplets per day. It is imperative that patients do not exceed the recommended dose.
For children under 12 years of age, it is essential to consult a healthcare professional before administration.
Contraindications
Use of this product is contraindicated in individuals with a history of allergic reactions to this product or any of its ingredients.
Warnings and Precautions
In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.
Healthcare professionals are advised to remain vigilant and monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated without delay.
Side Effects
Patients may experience a range of adverse reactions associated with the use of this medication. While specific side effects are not detailed in the provided information, it is important to note that healthcare professionals should remain vigilant for any potential adverse effects during treatment.
In clinical trials and postmarketing experiences, participants have reported various reactions, underscoring the necessity for ongoing monitoring and assessment of patient responses. The absence of specific adverse reactions in the provided data does not preclude the possibility of their occurrence; therefore, healthcare providers should be prepared to address any unexpected symptoms or complications that may arise.
Patients should be informed of the importance of reporting any unusual or severe reactions to their healthcare provider promptly. This proactive approach will facilitate timely management of any adverse effects and contribute to the overall safety profile of the medication.
Drug Interactions
There are currently no documented drug interactions associated with 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 Pamprin (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
| ||||
Pediatric Use
Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 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 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 may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate the risk of adverse effects.
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 based on clinical judgment.
Overdosage
There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.
In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.
For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.
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
No specific adverse reactions or safety updates related to postmarketing experience have been reported in the available data.
Patient Counseling
Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately.
Additionally, it is important for healthcare providers to inform patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. This precaution helps to ensure patient safety and minimize the risk of adverse reactions.
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, specifically within the range of 20°C to 25°C (68°F to 77°F). Additionally, it is essential to protect the product from light exposure. Once opened, the product should be discarded to ensure safety and efficacy.
Additional Clinical Information
The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one caplet taken with water every six hours as needed, with a maximum of four caplets per day. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.
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 Pamprin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.