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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Buscapina

Drug Facts

Active ingredients

Purpose

Active Ingredients (in each caplet)Purpose
Acetaminophen 500mgPain reliever
Caffeine 60mgDiuretic
Pyrilamine maleate 15mgAntihistamine

Uses

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

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 caplets 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 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 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 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, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, pvp K-30, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Buscapina 6 caplets

Buscapina

Acetaminophen, Caffeine, Pyrilamine Maleate Tablets

NDC 69729-132-06

6 Caplets

3 packs of 2 Caplets

Buscapina w6

BUSCAPINA 
acetaminophen, caffeine, pyrilamine maleate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeCAPSULESize17mm
FlavorImprint Code V1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-132-063 in 1 CARTON09/04/2023
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/04/2023
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Vovantis Laboratories Private Limited650502151manufacture(69729-132)

Revised: 9/2023
Document Id: 048ca26b-673c-e466-e063-6394a90aee6d
Set id: 048c4b03-1cf4-b724-e063-6294a90a1cad
Version: 1
Effective Time: 20230904
 
OPMX LLC