Label: ROLFIA- crataegus oxy, passiflore inc, rauwolfia ser, kali brom tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 1, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Crataegus Oxyacantha, Passiflora Incarnata, Rauwolfia Serpentina, Kali Bromatum

  • DOSAGE & ADMINISTRATION

    Adults: Take 2 tablets with water every 8 hours.

    Children under 18 years: Please consult physician.

  • Warnings:

    If symptons persist or worsen, a physician should be consulted. Keep out of reach of children. Do not use, if known sentivity to any of its ingredients exists. Replace cap tightly. If pregnant or breast feeding, ask a health care professional before use.

  • PURPOSE

    Tones up the Heart Muscle, Controls hypertension. Decrease Blood Pressure

  • Uses:

    Normalizes high blood pressure, conrols hypertension, tones up the heart muscle, treats arteriosclerosis and related symptoms like sleeplessness, irritability.

  • INACTIVE INGREDIENT

    Sugar of milk

  • DO NOT USE

    Do not use if neck wrap or foil inner seal is broken or missing. Protect from moisture, direct sunlight and heat.

  • PRINCIPAL DISPLAY PANEL

    Rolfia tablets label

  • INGREDIENTS AND APPEARANCE
    ROLFIA 
    crataegus oxy, passiflore inc, rauwolfia ser, kali brom tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69825-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE3 [hp_X]  in 100 g
    CRATAEGUS MONOGYNA LEAF (UNII: A2KER9748T) (CRATAEGUS MONOGYNA LEAF - UNII:A2KER9748T) CRATAEGUS MONOGYNA LEAF2 [hp_X]  in 100 g
    PASSIFLORA INCARNATA ROOT (UNII: 3952I8DXEX) (PASSIFLORA INCARNATA ROOT - UNII:3952I8DXEX) PASSIFLORA INCARNATA ROOT2 [hp_X]  in 100 g
    RAUWOLFIA SERPENTINA (UNII: H192N84N1G) (RAUWOLFIA SERPENTINA - UNII:H192N84N1G) RAUWOLFIA SERPENTINA2 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69825-007-021 in 1 BOX03/30/2016
    1NDC:69825-007-01100 g in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/30/2016
    Labeler - Adven Biotech Private Limited (858029164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adven Biotech Private Limited858029164manufacture(69825-007) , relabel(69825-007) , repack(69825-007)