BUSCAPINA- acetaminophen, caffeine and pyrilamine maleate tablet, film coated

Buscapina by

Drug Labeling and Warnings

Buscapina by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Purpose

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

Uses

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

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

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.

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

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

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

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.

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

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

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.

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

BUSCAPINA 
acetaminophen, caffeine and pyrilamine maleate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-813
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	500 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-813-24	2 in 1 CARTON	11/12/2025
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/12/2025

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		915664486	manufacture(69729-813)