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Buscapina

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Active ingredients
  • Acetaminophen 500 mg
  • Pyrilamine Maleate 15 mg
  • Caffeine 60 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet, 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 2022
Label revision date
January 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Pyrilamine Maleate 15 mg
  • Caffeine 60 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet, 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 2022
Label revision date
January 17, 2024
Manufacturer
OPMX LLC
Registration number
M013
NDC root
69729-131
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Buscapina is a combination medication that includes acetaminophen (a pain reliever), caffeine (a diuretic), and pyrilamine maleate (an antihistamine). It is designed to provide temporary relief from various symptoms associated with menstrual periods, such as cramps, bloating, water-weight gain, headaches, backaches, muscle aches, and fatigue.

By combining these ingredients, Buscapina helps alleviate discomfort and improve your overall well-being during menstruation. If you're experiencing these symptoms, this medication may offer you some relief.

Uses

If you're experiencing discomfort during your menstrual period, this medication can help provide temporary relief from a variety of symptoms. You may find it effective for alleviating cramps, bloating, and water-weight gain. Additionally, it can help ease headaches, backaches, muscle aches, and fatigue that often accompany your menstrual cycle.

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. Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Dosage and Administration

When taking this medication, it's important to follow the recommended dosage to ensure your safety. If you are an adult or a child aged 12 years and older, you should take 2 caplets with a glass of water. You can repeat this every 6 hours if needed, but make sure not to exceed a total of 6 caplets in one day.

For children under 12 years old, it's best to consult a doctor before giving them this medication. Remember, always take the caplets orally (by mouth) with water, and only take them as often as directed.

What to Avoid

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. Additionally, do not take this medication alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with a doctor or pharmacist before use. Taking these precautions will help ensure your safety while using this product.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed the maximum daily limit of 6 caplets, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious allergic reactions, including skin reddening, blisters, rashes, hives, facial swelling, asthma (wheezing), and shock. If you experience any of these symptoms, stop using the product and seek medical help immediately.

While using this product, you might feel drowsy, and excitability can occur, especially in children. It's important to avoid alcohol, sedatives, and tranquilizers, as they can increase drowsiness. If you notice new symptoms, redness, swelling, or if pain or fever worsens or lasts longer than the specified time, consult a doctor. Always check with a healthcare professional if you have liver disease, glaucoma, or other specific health concerns before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 6 caplets in 24 hours, use it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin or allergic reactions, such as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. If you experience any of these symptoms, stop using the product and seek medical help immediately.

Before using this medication, consult your doctor if you have liver disease, glaucoma, difficulty urinating due to an enlarged prostate, or breathing issues like emphysema or chronic bronchitis. It's also important to check with your doctor or pharmacist if you are taking blood thinners like warfarin or sedatives. In case of an overdose, seek emergency medical assistance or contact a Poison Control Center right away, even if you don't notice any symptoms.

You should stop using this product and call your doctor if you develop new symptoms, notice redness or swelling, experience worsening pain that lasts more than 10 days, or if a fever worsens or lasts more than 3 days.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 your child, it's important to consult a doctor first if your child is under 12 years old. For those aged 12 and older, the recommended dosage is 2 caplets taken with water every 6 hours as needed, but do not exceed 6 caplets in a day.

Be aware that some children may experience excitability as a side effect. Additionally, if you notice any concerning symptoms or if your child seems unwell, seek medical attention promptly, even if there are no obvious signs of distress. Your child's health and safety are the top priority.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s always important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems or renal impairment, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor regarding your kidney health when considering any new treatments.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 6 caplets in a 24-hour period can lead to severe liver damage. Additionally, avoid using this product alongside other medications that also contain acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using it.

Before starting this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this medication.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety.

Additionally, be cautious if you consume alcohol or take sedatives and tranquilizers while using this medication, as they may increase drowsiness. Always discuss any medications or substances you are using with your healthcare provider to avoid potential interactions and ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 68-77°F (20-25°C). This temperature range helps maintain the product's integrity.

When handling the product, be sure to check the packaging carefully. It is crucial not to use the product if the package is opened, or if the pouch is torn, broken, or shows any signs of tampering. Following these guidelines will help you use 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 2 caplets with water every 6 hours as needed, but do not exceed 6 caplets in a day. If the patient is under 12 years old, it's important to consult a doctor before use.

If you are pregnant or breastfeeding, please consult a healthcare professional before taking this medication. Always keep it out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

FAQ

What is Buscapina?

Buscapina is a medication that contains Acetaminophen, Caffeine, and Pyrilamine Maleate, used for the temporary relief of symptoms associated with menstrual periods.

What symptoms does Buscapina relieve?

Buscapina is used to relieve cramps, bloating, water-weight gain, headache, backache, muscle aches, and fatigue associated with menstrual periods.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2 caplets with water every 6 hours as needed, without exceeding 6 caplets per day.

What should I do if I am under 12 years old?

If you are under 12 years old, consult a doctor before using Buscapina.

Are there any contraindications for using Buscapina?

Do not use Buscapina with any other drug containing acetaminophen or if you have had an allergic reaction to this product or its ingredients.

What are the liver warnings associated with Buscapina?

Severe liver damage may occur if you take more than 6 caplets in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if I experience an allergic reaction?

If you experience symptoms like skin reddening, blisters, rash, hives, or facial swelling, stop use and seek medical help immediately.

Can I use Buscapina if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Buscapina.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

How should I store Buscapina?

Store Buscapina at room temperature between 68-77°F (20-25°C) and do not use if the package is opened or tampered with.

Packaging Info

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

Packaging configurations for Buscapina.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Buscapina is a combination medication in tablet form, specifically formulated as Acetaminophen, Caffeine, and Pyrilamine Maleate. Each tablet contains 500 mg of Acetaminophen, which serves as a pain reliever, 60 mg of Caffeine, acting as a diuretic, and 15 mg of Pyrilamine Maleate, an antihistamine. The product is packaged in a total of 144 caplets, distributed in 72 packs containing 2 caplets each. The National Drug Code (NDC) for this formulation is 69729-131-72. Buscapina is manufactured in India and is exclusively distributed by OPMX, located in San Diego, CA 92154. For inquiries, the contact number is 619-600-5632.

Uses and Indications

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

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 every 6 hours as needed. The total daily dosage must not exceed 6 caplets. For children under 12 years of age, it is essential to consult a healthcare professional prior to administration.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin or allergic reactions. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Healthcare professionals should advise patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

Patients should be instructed to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory issues such as emphysema or chronic bronchitis. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking blood thinners such as warfarin or sedatives/tranquilizers.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should be instructed to stop using this product and consult a healthcare provider if any of the following occur: new symptoms arise, redness or swelling is observed, pain worsens or persists for more than 10 days, or fever intensifies or lasts longer than 3 days.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients may also experience severe skin or allergic reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin or general allergic reaction, it is imperative that patients discontinue use and seek immediate medical assistance.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

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

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as be cautious when driving or operating machinery. Excitability may occur, particularly in children, and the combination of alcohol, sedatives, or tranquilizers may exacerbate drowsiness. Patients are also advised to limit the intake of caffeine-containing products, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

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 longer than 3 days.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring due to potential alterations in anticoagulant effects.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when engaging in activities that require alertness, and dosage adjustments may be necessary to mitigate the risk of excessive sedation.

Packaging & NDC

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

Packaging configurations for Buscapina.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For patients aged 12 years and older, the recommended dosage is 2 caplets taken with water, which may be repeated every 6 hours as needed, without exceeding 6 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. It is important for both adults and pediatric patients to seek quick medical attention, even in the absence of noticeable signs or symptoms.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 medication 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 or kidney problems should consult a healthcare professional prior to use. It is essential to assess renal function to determine the appropriateness of treatment and any necessary dosing adjustments or monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in instances where no signs or symptoms are apparent.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations, as early recognition and treatment can significantly influence outcomes.

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 postmarketing experience details are available in the insert text.

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, it is crucial to seek medical help 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 initially apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients to discontinue use and consult a doctor if they experience new symptoms, or if they notice any redness or swelling. Additionally, patients should be advised to stop using the product if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days.

Patients should be made aware that drowsiness may occur while using this product, and they should avoid alcoholic beverages during its use. Excitability may also be a side effect, particularly in children. Furthermore, patients should be cautioned that the use of alcohol, sedatives, or tranquilizers may enhance drowsiness.

When using this product, patients should exercise caution when driving or operating machinery. They should also limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine can 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.

Patients with liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or breathing problems such as emphysema or chronic bronchitis should be advised to consult a doctor before using this product. Additionally, patients taking the blood-thinning medication warfarin, or those on sedatives or tranquilizers, should seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to avoid using the product if the package is opened or if the pouch is torn, broken, or shows any signs of tampering.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 68-77°F (20-25°C). Proper handling and storage conditions are crucial to ensure the integrity and safety of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children 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. For children under 12 years, consultation with a healthcare professional is advised prior to use.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional before using the medication. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Buscapina, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.