Buscapina

Manufacturer
OPMX LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:43:24

Label at a glance#

ProductBuscapina
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure17 sections

Indications and 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

Do not exceed recommended dosage. Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day Children under 12 years: Consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Buscapina

Active Ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg,  Caffeine 60mg, and Pyrilamine maleate 15mg 

Purpose

OTC - PURPOSE SECTION

Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of these symptoms associated with menstrual periods
  • Cramps
  • Bloating
  • Water- weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue

Warnings

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not exceed recommended dosage.
  • Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
  • Children under 12 years: Consult a doctor

Other Information

OTC - QUESTIONS SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Colloidal silicon dioxide
  • Hypromellose
  • Magnesium stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Polyvinyl pyrrolidone
  • Pregelatinized starch
  • Titanium dioxide
  • Talc

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST

PLEASE REFER TO LEAFLET FOR INSTRUCTIONS IN SPANISH

CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL

Principal display panel 24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-130-24

Buscapina

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Malete 15 mg

Pain Reliever

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

Licenced by:

Gute Besserung Hauser LLC

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

2424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN4
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD4
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130856828008007GTIN-13: 0856828008007
EAN-13: 0856828008007
GTIN-12: 856828008007
UPC-A: 856828008007
GTIN storage (14 digits): 00856828008007
-Buscapina w24 Caplets 11.2025_001.jpg
QR code linkQR Codeopmx.us/-Buscapina w24 Caplets 11.2025_001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-130-24Buscapina24 in 1 BOTTLETABLET, COATED244

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-13069729-130-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-05-17full-release2026-06-01 00:12:44

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
ndc (package): 69729-130-24
ndc (product): 69729-130
ndc11 (package): 69729013024
spl id: 433fb0f8-517b-45a7-e063-6394a90a995e
spl set id: 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.