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Pyrilamine maleate/Acetaminophen/Caffeine

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Active ingredients
  • Acetaminophen 500 mg
  • Pyrilamine Maleate 15–500 mg
  • Caffeine 15–60 mg
Reference brand
Menstrual Relief
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage forms
  • Capsule
  • Capsule, Liquid Filled
  • Tablet
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2002
Label revision date
March 11, 2026
Active ingredients
  • Acetaminophen 500 mg
  • Pyrilamine Maleate 15–500 mg
  • Caffeine 15–60 mg
Reference brand
Menstrual Relief
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage forms
  • Capsule
  • Capsule, Liquid Filled
  • Tablet
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2002
Label revision date
March 11, 2026

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Drug Overview

Buscapina is a medication that combines three active ingredients: Acetaminophen, Caffeine, and Pyrilamine Maleate. It is designed to provide temporary relief from various symptoms associated with menstrual periods, including cramps, bloating, water-weight gain, headaches, backaches, muscle aches, and fatigue. Acetaminophen acts as a pain reliever, while Caffeine serves as a diuretic (helping to reduce water retention), and Pyrilamine Maleate functions as an antihistamine (which can help alleviate allergy-like symptoms).

This medication is available in tablet form and is intended for those seeking relief from the discomforts that can accompany menstruation. If you experience these symptoms, Buscapina may help you feel more comfortable during your menstrual cycle.

Uses

You can use this medication for the temporary relief of various symptoms associated with menstrual periods. These symptoms include cramps, bloating, water-weight gain, headaches, backaches, muscle aches, and fatigue.

This medication is designed to help alleviate discomfort during your menstrual cycle, making it easier for you to manage your daily activities. If you experience any of these symptoms, this medication may provide the relief you need.

Dosage and Administration

For adults and children aged 12 years and older, take 2 caplets (or gelcaps) with water every 6 hours as needed. Do not exceed 6 caplets (or gelcaps) in a 24-hour period. If you are under 12 years old, consult a doctor before use. Always follow the recommended dosage and do not take more than 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 it in combination with any other medication containing acetaminophen (a common pain reliever), whether prescription or over-the-counter. If you're unsure whether a drug contains acetaminophen, please consult a doctor or pharmacist for clarification.

There are no specific warnings regarding controlled substances, abuse, misuse, or dependence (a state where you rely on a substance to function normally) associated with this product. Always prioritize your safety and well-being by following these guidelines.

Side Effects

  • Taking products containing acetaminophen can lead to severe liver damage if you exceed the recommended dosage (generally more than 4,000 mg in 24 hours), use them with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using these products.

  • Be aware of potential severe allergic reactions, which may include symptoms like skin reddening, blisters, rash, 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 these medications, you may experience drowsiness, and excitability may occur, especially in children. Alcohol, sedatives, and tranquilizers can increase drowsiness, so use caution when driving or operating machinery.

  • Always consult a doctor before use if you have liver disease, glaucoma, difficulty urinating due to prostate enlargement, or breathing problems like emphysema or chronic bronchitis. Additionally, check with a healthcare professional if you are taking blood thinners like warfarin or sedatives.

  • If new symptoms arise, redness or swelling occurs, pain worsens or lasts more than 10 days, or fever persists for more than 3 days, stop using the product and consult a doctor, as these could indicate a serious condition.

Warnings and Precautions

  • This product contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it.

  • Be aware of potential severe allergic reactions, which may include symptoms like 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 product, consult a doctor if you have liver disease, glaucoma, difficulty urinating due to prostate enlargement, or breathing problems like emphysema or chronic bronchitis. Also, ask a doctor or pharmacist if you are taking blood thinners (like warfarin) or sedatives.

  • Stop using the product and call your doctor if you notice new symptoms, redness or swelling, pain that worsens or lasts more than 10 days, or fever that worsens or lasts more than 3 days, as these could indicate a serious condition.

  • In case of 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 present.

Overdose

In case of an overdose of any medication, it is crucial to seek medical help immediately or contact a Poison Control Center (1-800-222-1222). Quick medical attention is essential for both adults and children, even if you do not notice any signs or symptoms.

Be aware that taking more than 4,000 mg of acetaminophen in 24 hours can lead to severe liver damage. This risk increases if you take acetaminophen with other medications containing it or consume three or more alcoholic drinks daily while using these products. For some medications, the maximum daily amount is 6 to 8 tablets, depending on the specific product. Always follow the recommended dosage to avoid serious health risks.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any medications, including those for menstrual pain relief. This precaution applies to various products such as Buscapina, Midol Complete, and other menstrual relief tablets. Always prioritize your health and the health of your baby by seeking professional advice before taking any medication during this sensitive time.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any medication. This includes various forms of menstrual pain relief products, such as tablets and capsules. Always prioritize your health and the well-being of your baby by seeking guidance from a healthcare provider regarding the safety of any medication during this time.

Pediatric Use

For children under 12 years, it is important to consult a doctor before using any of these medications. Excitability may occur, especially in children, so monitor your child closely. For adults and children aged 12 years and older, the recommended dosage is to take 2 caplets (or gelcaps) with water every 6 hours as needed, without exceeding 6 caplets (or gelcaps) in a 24-hour period.

In case of an overdose, seek medical help immediately or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even if no symptoms are apparent.

Geriatric Use

You may find that many medications for menstrual pain relief, such as Menstrual Pain Relief Complete, Midol Complete, and Buscapina, do not provide specific information regarding their use in older adults. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions for elderly patients.

If you are an older adult or a caregiver, it's important to consult with a healthcare professional before using these medications. They can help assess your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and seek personalized advice.

Renal Impairment

When considering medications like Buscapina, Midol Complete, and various menstrual relief products, it's important to note that there is generally no specific information provided regarding dosage adjustments or safety considerations for individuals with kidney problems. However, if you have renal impairment or any kidney issues, it is advisable to consult your doctor before using these medications. This ensures that you receive appropriate guidance tailored to your health needs.

Always remember to inform your healthcare provider about any existing kidney conditions, as they can help determine the best course of action for your treatment.

Hepatic Impairment

You should be aware that several products containing acetaminophen can lead to severe liver damage if not used properly. To avoid this risk, do not exceed the maximum daily dosage, which is typically 4,000 mg or 6 caplets/tablets in 24 hours, depending on the specific product. Additionally, combining these medications with other acetaminophen-containing drugs or consuming three or more alcoholic drinks daily while using them can significantly increase the risk of liver damage.

If you have liver disease or any liver-related concerns, it is essential to consult a doctor before using these products. Always follow the recommended guidelines to ensure your safety.

Drug Interactions

When using products that contain acetaminophen, such as various menstrual pain relief medications, it's important to be cautious if you're also taking warfarin, a blood thinner. Combining these can increase the risk of bleeding, so monitoring your INR levels (a measure of blood clotting) is essential. Additionally, using alcohol, sedatives, or tranquilizers with these medications may enhance drowsiness, so it's wise to avoid or limit their use.

Always discuss your medications and any potential interactions with your healthcare provider. This is crucial for ensuring your safety and the effectiveness of your treatments, as they can provide personalized advice based on your health history and current medications.

Storage and Handling

To ensure the effectiveness of your medication, store it at room temperature, ideally between 68-77°F (20-25°C) for products like Buscapina and Midol Complete. For other medications, such as various Menstrual Relief tablets, a slightly higher temperature of 77°F (25°C) is recommended, with acceptable variations between 59°F and 86°F (15-30°C). Avoid exposing the products to excessive heat above 104°F (40°C) and humidity.

Always check the packaging for any signs of tampering, such as opened or broken seals, and do not use the product if these conditions are present. Additionally, be sure to look for the expiration date and lot number on the end flap of the package to ensure safety and efficacy. For disposal, follow local guidelines for medication disposal to prevent environmental contamination.

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

  • Fatigue

Limitations of Use No teratogenic or nonteratogenic effects have been mentioned for this drug.

Dosage and Administration

Adults and children 12 years and older are instructed to take 2 caplets with water every 6 hours as needed. The total daily dosage must not exceed 6 caplets. For children under 12 years, it is advised to consult a doctor before use.

It is essential to adhere to the recommended dosage and not exceed the specified limits. The medication should be taken orally with water.

Contraindications

Do not use in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a doctor or pharmacist is advised.

Additionally, do not use if there has been a prior allergic reaction to this product or any of its ingredients.

Warnings and Precautions

Liver Warnings This product contains acetaminophen. Severe liver damage may occur if taken:

  • More than 4,000 mg of acetaminophen in 24 hours.

  • With other drugs containing acetaminophen.

  • With 3 or more alcoholic drinks every day while using this product.

Allergy Alerts Acetaminophen may cause severe skin or allergic reactions. Symptoms may include:

  • Skin reddening

  • Blisters

  • Rash

  • Hives

  • Facial swelling

  • Asthma (wheezing)

  • Shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

General Precautions

  • Do not use with any other drug containing acetaminophen (prescription or nonprescription). If unsure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • Ask a doctor before use if you have:

    • Liver disease

    • Glaucoma

    • Difficulty in urination due to enlargement of the prostate gland

    • A breathing problem such as emphysema or chronic bronchitis

  • Ask a doctor or pharmacist before use if you are:

    • Taking the blood-thinning drug warfarin

    • Taking sedatives or tranquilizers

Monitoring Requirements When using this product:

  • You may get drowsy; avoid alcoholic drinks.

  • Excitability may occur, especially in children.

  • Alcohol, sedatives, and tranquilizers may increase drowsiness.

  • Be careful when driving a motor vehicle or operating machinery.

  • Limit the use of caffeine-containing medications, foods, or beverages, as too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if no signs or symptoms are noticed.

Stop Taking and Call Your Doctor Stop use and ask a doctor if:

  • New symptoms occur.

  • Redness or swelling is present.

  • Pain gets worse or lasts more than 10 days.

  • Fever gets worse or lasts more than 3 days. These could be signs of a serious condition.

Side Effects

Severe liver damage may occur if patients take more than 4,000 mg of acetaminophen in 24 hours, with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Allergy Reactions

Acetaminophen may cause severe skin or allergic reactions. Symptoms may include:

  • Skin reddening

  • Blisters

  • Rash

  • Hives

  • Facial swelling

  • Asthma (wheezing)

  • Shock

If any of these symptoms occur, patients should stop use and seek medical help immediately.

Additional Warnings

  • Patients may experience drowsiness; therefore, caution is advised when driving or operating machinery.

  • Alcohol, sedatives, and tranquilizers may increase drowsiness.

  • Excitability may occur, especially in children.

  • Limit the use of caffeine-containing medications, foods, or beverages, as excessive caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

When to Stop Use

Patients should stop use and consult a doctor if:

  • New symptoms occur

  • Redness or swelling is present

  • Pain worsens or lasts more than 10 days

  • Fever worsens or lasts more than 3 days

These could be signs of a serious condition.

Special Considerations

Patients should consult a doctor before use if they have:

  • Liver disease

  • Glaucoma

  • Difficulty urinating due to enlargement of the prostate gland

  • A breathing problem such as emphysema or chronic bronchitis

Patients should also consult a doctor or pharmacist before use if they are taking:

  • The blood-thinning drug warfarin

  • Sedatives or tranquilizers

Overdose Warning

In case of overdose, patients should seek medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Drug Interactions

Taking medications that contain acetaminophen may lead to several significant interactions, particularly with anticoagulants and substances that can enhance sedation.

Pharmacokinetic Interactions

  • Warfarin: Acetaminophen has been shown to potentially increase the effects of warfarin, leading to an increased risk of bleeding. It is advised to monitor International Normalized Ratio (INR) levels closely when these medications are used together. This interaction is noted across multiple products, including those labeled as Menstrual Pain Relief, Menstrual Relief, and others containing acetaminophen.

Pharmacodynamic Interactions

  • Alcohol, Sedatives, and Tranquilizers: Concurrent use of alcohol, sedatives, and tranquilizers with acetaminophen may enhance drowsiness. Caution is advised when using these combinations, as they can significantly impair the ability to perform tasks that require alertness, such as driving or operating machinery. This warning is consistent across various formulations, including those containing caffeine and pyrilamine maleate.

  • Caffeine: The presence of caffeine in some formulations may lead to increased nervousness, irritability, and sleeplessness. It is recommended to limit the use of additional caffeine-containing medications while taking products that include acetaminophen and caffeine.

Liver Toxicity

  • Acetaminophen Overdose Risk: Acetaminophen may increase the risk of severe liver damage when taken with other products containing acetaminophen or when consumed with three or more alcoholic drinks daily. This risk is particularly highlighted in formulations labeled as Menstrual Relief.

In summary, caution is warranted when using acetaminophen-containing products, especially in conjunction with warfarin, alcohol, sedatives, and caffeine, due to the potential for increased bleeding risk and enhanced sedation. Monitoring and careful management of these interactions are essential for patient safety.

Pediatric Use

Children under 12 years should consult a doctor before use of these medications. Excitability may occur, especially in children. In case of overdose, prompt medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

For dosing, adults and children 12 years and older are advised to take 2 caplets or gelcaps with water every 6 hours as needed, without exceeding 6 caplets or gelcaps in a 24-hour period.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the following medications: Menstrual Pain Relief Complete, Midol Complete, Buscapina, Acetaminophen, Caffeine and Pyrilamine Maleate, and various formulations of Menstrual Relief and Menstrual Complete.

Healthcare professionals should exercise caution when prescribing these medications to geriatric patients, as the absence of specific data necessitates careful monitoring for potential adverse effects and the need for dose modifications based on individual patient assessments.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the medications listed, including Buscapina, Midol Complete, Menstrual Pain Relief Complete, and various formulations of Menstrual Relief and Menstrual Complete. The safety of these medications during pregnancy has not been established, and potential risks to fetal outcomes are not clearly defined in the available data.

All formulations, including tablets and film-coated options, carry the recommendation to seek professional advice if the patient is pregnant or breastfeeding. This precaution is essential to ensure the safety of both the mother and the developing fetus, as the effects of these medications during pregnancy have not been thoroughly studied. Therefore, healthcare providers should evaluate the risks and benefits before recommending these products to pregnant patients.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the medications listed, including various formulations for menstrual pain relief. This recommendation applies to all forms, including tablets and capsules, as the safety of these medications during breastfeeding has not been established.

There is no specific data provided regarding the excretion of these medications in breast milk or their potential effects on breastfed infants. Therefore, healthcare providers should exercise caution and consider the benefits versus risks when recommending these products to lactating mothers.

Renal Impairment

Patients with renal impairment should be aware that the available drug inserts for various medications, including Buscapina, Midol Complete, and several formulations of Menstrual Relief products, do not provide specific information regarding dosage adjustments, monitoring, or safety considerations for those with reduced kidney function.

In particular, while most labels lack detailed guidance, one label for Buscapina advises patients to consult a healthcare professional if they have renal impairment or kidney problems. This suggests a precautionary approach, emphasizing the importance of medical consultation before use in this patient population.

Overall, due to the absence of comprehensive data on renal impairment across these products, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these medications to patients with compromised kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen. Severe liver damage may occur if they exceed the following limits:

  • More than 4,000 mg of acetaminophen in 24 hours.

  • The maximum daily amount specified for the product, which may vary (e.g., 6 caplets or tablets for certain formulations).

  • Concurrent use with other medications containing acetaminophen.

  • Consumption of 3 or more alcoholic drinks daily while using these products.

It is advised that patients with liver disease consult a healthcare professional before using these products. Monitoring of liver function may be warranted, particularly in patients with pre-existing liver conditions.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Quick medical attention is crucial for both adults and children, even if no symptoms are initially apparent.

Symptoms of overdose may include severe liver damage, particularly in cases involving acetaminophen. It is important to note that severe liver damage can occur if an individual consumes more than 4,000 mg of acetaminophen within a 24-hour period, takes acetaminophen in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using products containing acetaminophen. For certain formulations, the maximum daily dosage is limited to six caplets or tablets.

Monitoring for symptoms of liver damage is essential, as early intervention can significantly impact outcomes. Individuals should be aware of the risks associated with exceeding recommended dosages and the potential for serious health consequences.

Nonclinical Toxicology

Teratogenic Effects

No teratogenic effects were noted in animal studies for Acetaminophen, Caffeine and Pyrilamine Maleate. However, for other products, no information regarding teratogenic effects is provided in the inserts.

Non-Teratogenic Effects

For Acetaminophen, Caffeine and Pyrilamine Maleate, no increase in fetal malformations was observed in animal studies. Other products similarly lack information on non-teratogenic effects.

Nonclinical Toxicology

No specific nonclinical toxicology details are provided in the inserts for any of the products reviewed.

Animal Pharmacology and Toxicology

There is no information available regarding animal pharmacology and toxicology for the products listed.

Storage and Handling

Buscapina is supplied in coated tablet form. It should be stored at room temperature between 68-77°F (20-25°C). The product is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any sign of tampering.

Menstrual Pain Relief Complete, Menstrual Complete, Menstrual Relief, and similar products are available in film-coated tablet form. These should be stored at 25°C (77°F), with excursions permitted between 15°-30°C (59°-86°F). It is important to check the end flap for the expiration date and lot number. Additionally, these products are tamper evident; do not use if the outer package is opened or if the blister is torn or broken.

Midol Complete is offered in coated tablet form and should be stored at room temperature. It is advised to avoid excessive heat above 104°F (40°C).

Acetaminophen, Caffeine, and Pyrilamine Maleate capsules and tablets are supplied in liquid-filled and standard forms, respectively. These should be stored at room temperature.

Menstrual Complete Gelcaps are also available in coated tablet form and should be stored at room temperature, avoiding excessive heat above 104°F (40°C).

All products should be handled with care, ensuring that storage conditions are maintained to preserve their efficacy and safety.

Product Labels

The table below lists all over-the-counter labels containing pyrilamine maleate, acetaminophen, and caffeine. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Acetaminophen, caffeine, pyrilamine maleate Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

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

FDA-Approved Acetaminophen, caffeine, pyrilamine maleate Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Strength range
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 68 FDA Structured Product Labels (DailyMed) for Acetaminophen, Caffeine, Pyrilamine Maleate (marketed as Buscapina, Menstrual Pain Relief Complete, Midol Complete), with data retrieved by a validated AI data-extraction workflow. This includes 68 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. No human clinician has reviewed this version.

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Last AI update:

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.