BUSCAPINA (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [OPMX LLC]

BUSCAPINA (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [OPMX LLC]
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NDC 69729-130-24
Set ID 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b
Category HUMAN OTC DRUG LABEL
Packager OPMX LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Drug Facts

    Buscapina

  • Active Ingredients (in each caplet)

    Acetaminophen 500mg, Caffeine 60mg, and Pyrilamine maleate 15mg 

  • Purpose

    Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

  • 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 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 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

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    • Do not exceed recommended dosage.
    • Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
    • Children under 12 years: Consult a doctor
  • Other Information

    • Store at room temperature
    • TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    • Colloidal silicon dioxide
    • Hypromellose
    • Magnesium stearate
    • Microcrystalline cellulose
    • Polyethylene glycol
    • Polyvinyl pyrrolidone
    • Pregelatinized starch
    • Titanium dioxide
    • Talc
  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM or www.healthlifeofusa.com

  • BuscapinaAcetaminophen 500mgCaffeine 60mgPyrilamine maleate 15mg24 CapletsDistributed By:OPMXSan Diego, CA, 92154

    image description

  • INGREDIENTS AND APPEARANCE
    BUSCAPINA 
    acetaminophen, caffeine, pyrilamine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-130
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-130-2424 in 1 BOTTLE; Type 0: Not a Combination Product01/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/05/2018
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Limited915664486manufacture(69729-130)

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