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

  • NDC Code(s): 69729-131-50, 69729-131-72
  • Packager: OPMX LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 17, 2024

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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
    • water-weight gain
    • headache
    • backache
    • muscle aches
    • fatigue
  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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

    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

    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

    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

    • 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

  • 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

  • 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)  
    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)
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