Buscapina New

Buscapina New
SPL v1
SPL
SPL Set ID 436b3716-1c87-bfba-e063-6394a90a1e12
Route
ORAL
Published
Effective Date 2025-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-12
Description

Drug Facts

Purpose

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

Medication Information

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

Description

Drug Facts

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Section 51945-4

NDC-69729-131-24

Buscapina

Acetaminophen 500 mg

Caffeine 60mg

Pyrilamine Maleate 15mg

Pain Reliever

  • Cramps/Cólicos
  • Bloating/Hinchazón
  • Fatigue/Fatiga
  • Headache/ Dolor de cabeza
  • Backache/Dolor de espalda

24 Caplets

Warnings

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

more than 6 tablets 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.

Allergy warning: 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.

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 allergic reaction to this product or any of its ingredients

Drug Facts

Drug Facts

Questions?

Call toll free 619-600-5632

Monday through Friday 9AM-5PM EST

PLEASE REFER TO LEAFLET INSTRUCTUIONS IN SPANISH

CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL

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
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 symtoms.

Inactive Ingredientes

colloidal silicon dioxide,

hydroxy propyl methyl cellulose,

magnesium stearate,

microcrystalline cellulose,

polyethylene glycol,

pregelatinized starch,

pvp K-30,

sodium starch glycolate,

stearic acid,

talc,

titanium dioxide.

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 aboout 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 Children

Keep out of reach of children

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • difficulty un rination due to the enlargement of the prostate gland
  • a breathing problem sucha 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
Section 51945-4 (51945-4)

NDC-69729-131-24

Buscapina

Acetaminophen 500 mg

Caffeine 60mg

Pyrilamine Maleate 15mg

Pain Reliever

  • Cramps/Cólicos
  • Bloating/Hinchazón
  • Fatigue/Fatiga
  • Headache/ Dolor de cabeza
  • Backache/Dolor de espalda

24 Caplets

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

Warnings

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

more than 6 tablets 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.

Allergy warning: 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.

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 allergic reaction to this product or any of its ingredients

Drug Facts

Drug Facts

Questions?

Call toll free 619-600-5632

Monday through Friday 9AM-5PM EST

PLEASE REFER TO LEAFLET INSTRUCTUIONS IN SPANISH

CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL

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
In Case of Overdose (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 symtoms.

Inactive Ingredientes (Inactive ingredientes)

colloidal silicon dioxide,

hydroxy propyl methyl cellulose,

magnesium stearate,

microcrystalline cellulose,

polyethylene glycol,

pregelatinized starch,

pvp K-30,

sodium starch glycolate,

stearic acid,

talc,

titanium dioxide.

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 aboout 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 Children (Keep out of reach of children)

Keep out of reach of children

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • difficulty un rination due to the enlargement of the prostate gland
  • a breathing problem sucha 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:12.543381 · Updated: 2026-03-14T23:10:26.709421