BUSCAPINA- acetaminophen, caffeine, pyrilamine maleate tablet, coated 
OPMX LLC

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Buscapina

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

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:

Warnings

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

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

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

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

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 about 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 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.

Directions

Other information

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

Questions or comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

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

Dolor de Cabeza

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

carton

packet

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

b100

BUSCAPINA 
acetaminophen, caffeine, pyrilamine maleate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE (UNII: FZ989GH94E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeCAPSULESize17mm
FlavorImprint Code V1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-131-7272 in 1 CARTON06/06/2022
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:69729-131-5050 in 1 CARTON12/05/2023
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/06/2022
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Vovantis Laboratories Private Limited650502151manufacture(69729-131)

Revised: 1/2024
Document Id: 0f2e22c3-c6e7-79a9-e063-6294a90aabde
Set id: e0dd4c04-6811-38a1-e053-2995a90aa3c9
Version: 3
Effective Time: 20240117
 
OPMX LLC