Buscapina

Buscapina
SPL v3
SPL
SPL Set ID e0dd4c04-6811-38a1-e053-2995a90aa3c9
Route
ORAL
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: V1 Shape: capsule Color: white Size: 17 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-06
Description

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine Maleate 15 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Dosage and Administration

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
Description

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine Maleate 15 mg

Section 42229-5

Liver Warning:

This product contains acetaminophen. Sever liber damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily ammount for this product.
  • wtih other drugs containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product
Section 44425-7

Other information

  • store at room temperature 68-77°F (20-25°C)
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Section 50565-1

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.

Section 50566-9

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

Section 50567-7

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.
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

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
Section 50570-1

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
Section 51727-6

Inactive ingredients

Colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 53413-1

Questions or comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Acetaminophen 500 mg . . . . . . . . . . Pain reliever

Caffeine 60 mg . . . . . . . . . . . . . . . . . Diuretic

Pyrilamine Maleate 15 mg . . . . . . . . Antihistamine

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Principal Display Panel Buscapina 100 Caplets

NDC 69729-131-50

Buscapina

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Pain Reliever

Cramps/Cólicos

Bloating/Hinchazón

Fatigue/Fatiga

Headache/Dolor de Cabeza

Backache/Dolor de Espalda

100 Caplets/ 50 packs of 2 Caplets

Principal Display Panel Buscapina 144 Caplets

Buscapina

Acetaminophen, Caffeine, Pyrilamine Maleate Tablets

NDC 69729-131-72

Acetaminophen 500 mg . . . . . . . Pain reliever

Caffeine 60 mg . . . . . . . . . . . . . . Diuretic

Pyrilamine Maleate 15 mg . . . . . Antihistamine

  • Cramps / Colicos
  • Bloating / Hinchzon
  • Fatigue / Fatiga
  • Heacache

Dolor de Cabeza

  • Backache

Dolor de Espalda

144 Caplets

72 packs of 2 Caplets

Made in India

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

Structured Label Content

Indications and Usage (34067-9)

Uses

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Liver Warning:

This product contains acetaminophen. Sever liber damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily ammount for this product.
  • wtih other drugs containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product
Section 44425-7 (44425-7)

Other information

  • store at room temperature 68-77°F (20-25°C)
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

Colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Acetaminophen 500 mg . . . . . . . . . . Pain reliever

Caffeine 60 mg . . . . . . . . . . . . . . . . . Diuretic

Pyrilamine Maleate 15 mg . . . . . . . . Antihistamine

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Principal Display Panel Buscapina 100 Caplets (Principal Display Panel - Buscapina 100 Caplets)

NDC 69729-131-50

Buscapina

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Pain Reliever

Cramps/Cólicos

Bloating/Hinchazón

Fatigue/Fatiga

Headache/Dolor de Cabeza

Backache/Dolor de Espalda

100 Caplets/ 50 packs of 2 Caplets

Principal Display Panel Buscapina 144 Caplets (Principal Display Panel - Buscapina 144 Caplets)

Buscapina

Acetaminophen, Caffeine, Pyrilamine Maleate Tablets

NDC 69729-131-72

Acetaminophen 500 mg . . . . . . . Pain reliever

Caffeine 60 mg . . . . . . . . . . . . . . Diuretic

Pyrilamine Maleate 15 mg . . . . . Antihistamine

  • Cramps / Colicos
  • Bloating / Hinchzon
  • Fatigue / Fatiga
  • Heacache

Dolor de Cabeza

  • Backache

Dolor de Espalda

144 Caplets

72 packs of 2 Caplets

Made in India

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:42.665875 · Updated: 2026-03-14T23:02:25.522673