Label: BUSCAPINA- acetaminophen, caffeine, pyrilamine maleate tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 7, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 60 mg

    Pyrilamine Maleate 15 mg

  • PURPOSE

    Purpose

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

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

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

  • INDICATIONS & USAGE

    Uses

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

    • cramps • bloating • headache • backache • fatigue

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not exceed recommended dosage
    • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 6 caplets per day
      • children under 12 years: do not use
  • SPL UNCLASSIFIED SECTION

    Other information

    • store betrween 15-30°C (59-86°F)
    • avoid excessive heat & humidity
    • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
  • INACTIVE INGREDIENT

    Inactive ingredients

    Colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose, microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call toll free 619-600-5632

    Monday through Friday 9AM - 5PM EST

  • 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

    carton

    packet

  • INGREDIENTS AND APPEARANCE
    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)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/06/2022
    Labeler - OPMX LLC (029918743)
    Registrant - Vovantis Laboratories Private Limited (650502151)
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