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Midol Bloat Relief
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- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Tablet
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2021
- Label revision date
- December 4, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Pamabrom 50 mg
- Other brand names
- Dosage form
- Tablet
- 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 2021
- Label revision date
- December 4, 2025
- Manufacturer
- Bayer HealthCare LLC.
- Registration number
- M027
- NDC root
- 0280-0070
- Drug Information (PDF)
- Prescribing information, PDF file
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Drug Overview
Midol® Bloat Relief is a medication that contains pamabrom, which is classified as a diuretic. This means it helps your body eliminate excess water. You can use Midol® Bloat Relief for the temporary relief of bloating, water-weight gain, swelling, and the full feeling that often occurs during your premenstrual and menstrual periods. It is designed to help you feel more comfortable during these times.
Uses
If you're experiencing discomfort from bloating, water-weight gain, or swelling, this medication can provide temporary relief. It’s particularly helpful for those full feelings that often accompany the premenstrual and menstrual periods.
You can rely on this treatment to ease these common symptoms, allowing you to feel more comfortable during those times. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.
Dosage and Administration
When using 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 the person needing the medication is under 12 years old, it's best to consult a doctor for guidance on the appropriate dosage. Always follow these instructions carefully to help manage your symptoms 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 this medication. You should not use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Allergic reactions can range from mild symptoms, like rashes, to severe reactions that may require immediate medical attention.
Always consult with your healthcare provider if you have any concerns about your medical history or if you experience any unusual symptoms while using this medication. Your safety is a priority, and understanding these warnings can help you make informed decisions about your health.
Warnings and Precautions
You should not use this product if you have ever had an allergic reaction to it or any of its ingredients. If you are pregnant or breastfeeding, it’s important to consult a healthcare professional before using this product to ensure it’s safe for you.
In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately. There are no specific laboratory tests required for this product, but always stay informed about your health and any potential risks.
Overdose
If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.
Don’t wait to see if symptoms improve; prompt action can be vital. Always keep emergency contact information handy, and remember that your health and safety are the top priority.
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 their age and health needs. Always prioritize your child's well-being by seeking professional guidance when it comes to their medication.
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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.
If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. Always prioritize safety and open communication with your healthcare team.
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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).
Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.
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 health conditions you have to receive the best care possible.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness and safety.
When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.
Additional Information
No further information is available.
FAQ
What is Midol® Bloat Relief used for?
Midol® Bloat Relief is used for the temporary relief of bloating, water-weight gain, swelling, and the full feeling associated with premenstrual and menstrual periods.
What is the active ingredient in Midol® Bloat Relief?
The active ingredient in Midol® Bloat Relief is Pamabrom, which is classified as a diuretic.
What is the recommended dosage for adults and children over 12?
Adults and children 12 years and older should take 1 caplet with water every 6 hours as needed, not exceeding 4 caplets per day.
What should I do if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using Midol® Bloat Relief.
Are there any contraindications for using this product?
You should not use Midol® Bloat Relief if you have ever had an allergic reaction to this product or any of its ingredients.
What should I do in case of an overdose?
In case of overdose, you should get medical help or contact a Poison Control Center right away.
How should I store Midol® Bloat Relief?
Store Midol® Bloat Relief between 20°-25°C (68°-77°F).
What is the packaging information for Midol® Bloat Relief?
The carton contains 60 caplets.
Packaging Info
Below are the non-prescription pack sizes of Midol Bloat Relief (pamabrom). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet | 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 Midol Bloat Relief, 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 symptoms associated with the premenstrual and menstrual periods, including bloating, water-weight gain, swelling, and a full feeling.
There are no teratogenic or nonteratogenic effects associated with 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. It is imperative that the total daily dosage does not exceed 4 caplets.
For children under 12 years of age, it is recommended to consult a healthcare professional prior to administration to determine the appropriate dosage and ensure safety.
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
It is imperative that this product is not used by individuals who have a history of allergic reactions to it or any of its components. Such reactions can pose significant health risks and should be strictly avoided.
For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use. This precaution is necessary to ensure the safety of both the mother and the child, as the effects of the product during these periods may not be fully understood.
In the event of an overdose, immediate medical assistance should be sought. It is crucial to contact a Poison Control Center or seek emergency medical help without delay to mitigate potential adverse effects.
No specific laboratory tests have been identified for monitoring during the use of this product. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment as part of standard care practices.
Side Effects
Patients should be aware that the use of this product is contraindicated in individuals who have a history of allergic reactions to this product or any of its ingredients. This warning is critical to prevent serious allergic responses that may occur upon administration.
In clinical trials and postmarketing experiences, no additional adverse reactions have been reported beyond those associated with allergic reactions. Therefore, healthcare providers should carefully evaluate the patient's medical history for any previous allergic responses before prescribing this product.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Midol Bloat Relief (pamabrom). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet | 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
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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 on 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 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 prescribing information.
Overdosage
In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.
Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain aware of the general signs of overdose, which may include but are not limited to altered mental status, respiratory distress, or cardiovascular instability.
Management of an overdose should be guided by the severity of symptoms and the specific substance involved. Supportive care is often necessary, and healthcare providers should be prepared to implement appropriate interventions based on the clinical presentation of the patient. Continuous monitoring and assessment are vital to ensure patient safety and to facilitate effective treatment.
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 use of the compound in these contexts.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.
In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°-25°C (68°-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Midol Bloat Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.