FDA.reportPublic FDA data

Buscapina

Manufacturer
OPMX LLC | Vovantis Laboratories Private Limited
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:31

Label at a glance#

ProductBuscapina
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

OTC - PURPOSE SECTION

Purpose

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

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

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

INDICATIONS & USAGE SECTION

Uses

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

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

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 reactions occurs, stop use and seek medical help right away

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Principal Display Panel - Buscapina 144 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

cartoncarton

packetpacket

Principal Display Panel - Buscapina 100 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

b100b100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN3
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD3
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-131-50Buscapina2 in 1 POUCHTABLET, COATED23
69729-131-50Buscapina50 in 1 CARTONTABLET, COATED503
69729-131-72Buscapina2 in 1 PACKETTABLET, COATED23
69729-131-72Buscapina72 in 1 CARTONTABLET, COATED723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-131BUSCAPINA (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [OPMX LLC]3Current NDC, Legacy NDC, 4 package rows20240118_e0dd4c04-6811-38a1-e053-2995a90aa3c9.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-13169729-131-72, 69729-131-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POVIDONEFZ989GH94EIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

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 LLCe0dd4c04-6811-38a1-e053-2995a90aa3c92024-01-17WarningsExact identifier
ndc (package): 69729-131-50
ndc (package): 69729-131-72
ndc (product): 69729-131
ndc11 (package): 69729013150
ndc11 (package): 69729013172
spl id: 0f2e22c3-c6e7-79a9-e063-6294a90aabde
spl set id: e0dd4c04-6811-38a1-e053-2995a90aa3c9

Reported adverse events (FAERS/openFDA)#

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