Buscapina

Buscapina
SPL v2
SPL
SPL Set ID 048c4b03-1cf4-b724-e063-6294a90a1cad
Route
ORAL
Published
Effective Date 2023-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrilamine (15 mg) Acetaminophen (500 mg) Caffeine (60 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Magnesium Stearate Povidone K30 Stearic Acid Hypromellose, Unspecified Talc Microcrystalline Cellulose Sodium Starch Glycolate Type A Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: V1 Shape: capsule Color: white Size: 17 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-04
Description

Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine

Purpose

Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine

Medication Information

Purpose
Active Ingredients (in each caplet) Purpose
Acetaminophen 500mg Pain reliever
Caffeine 60mg Diuretic
Pyrilamine maleate 15mg Antihistamine

Description

Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine

Uses

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Directions
  • do not exceed recommended dosage
  • adults and children 12 years and over: take 2 caplets with water. Repeat every 6 hours as needed. Do not exceed 6 caplets per day.
    • children under 12 years: consult a doctor
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist
  • if you have ever had an allertgic reaction to this product or any of its ingredients
Allergy Alert

Acetaminophen may cause severe skin or severe 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.

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Other Information
  • store at room temperature 68-77°F (20-25°C)
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Active Ingredients

Buscapina 6 Caplets

Buscapina

Acetaminophen, Caffeine, Pyrilamine Maleate Tablets

NDC 69729-132-06

  • Cramps
  • Bloating
  • Fatigue
  • Heacache
  • Backache

6 Caplets

3 packs of 2 Caplets

Inactive Ingredients

colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, pvp K-30, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

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 because too much caffeine may cause nervousness, irritability sleeplessness, and, occasionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop Use and Ask A Doctor If
  • new symptoms appear
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Chlidren.

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 you do not notice any signs or symptoms.

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

Structured Label Content

Uses

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Purpose
Active Ingredients (in each caplet) Purpose
Acetaminophen 500mg Pain reliever
Caffeine 60mg Diuretic
Pyrilamine maleate 15mg Antihistamine

Directions
  • do not exceed recommended dosage
  • adults and children 12 years and over: take 2 caplets with water. Repeat every 6 hours as needed. Do not exceed 6 caplets per day.
    • children under 12 years: consult a doctor
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist
  • if you have ever had an allertgic reaction to this product or any of its ingredients
Allergy Alert (Allergy alert)

Acetaminophen may cause severe skin or severe 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.

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Other Information (Other information)
  • store at room temperature 68-77°F (20-25°C)
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Active Ingredients (Active ingredients)

Buscapina 6 Caplets (Buscapina 6 caplets)

Buscapina

Acetaminophen, Caffeine, Pyrilamine Maleate Tablets

NDC 69729-132-06

  • Cramps
  • Bloating
  • Fatigue
  • Heacache
  • Backache

6 Caplets

3 packs of 2 Caplets

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, pvp K-30, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

When Using This Product (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 because too much caffeine may cause nervousness, irritability sleeplessness, and, occasionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms appear
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Chlidren. (Keep out of reach of chlidren.)

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 you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:36.018457 · Updated: 2026-03-14T23:05:28.061539