Label: RXHOMEO HOMEOPATHIC COMBO kit

  • 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 October 13, 2016

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

  • ACTIVE INGREDIENT

    PASSIFLORA INCARNATA HPUS 3X and higher

    KALI PHOSPHORICUM HPUS 1X and Higher

  • USES

    A homeopathic combination pack with two single remedies Passiflora Incarnata and Kali Phosphoricum for relief of sleeplessness.


    Passiflora Incarnata; Uses: Passiflora Incarnata is a chief remedy for insomnia or sleeplessness. Passiflora helps in quietning the nervous system and induces normal sleep. Restlessness and wakeful sleep especially in the feeble, infants, and the aged with history of mental worries and over work.


    Kali Phosphoricum;Uses: Kali Phosphoricum helps in insomnia or sleeplessness after worry or excitement from nervous causes. Also walking in sleep in children.

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE

    PELLETS included in the Combo

    Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

    TABLETS included in the Combo

    Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    Keep this and all medication out of reach of children

    Do not use if capseal is broken or missing.

    Close the cap tightly after use.

  • INACTIVE INGREDIENTS

    Sucrose for Pellets.

    Lactose for Tablets.

  • STORAGE

    Store in a cool dark place

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com
    Rxhomeo, Inc 1504 Fairway Dr. Ste W 100 Lewisville, TX 75057 USA

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RXHOMEO HOMEOPATHIC COMBO 
    rxhomeo homeopathic combo kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2483
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-2483-01 in 1 CONTAINER10/10/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    PASSIFLORA INCARNATA 
    passiflora incarnata pellet
    Product Information
    Item Code (Source)NDC:15631-0331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic
    Part 2 of 2
    KALI PHOSPHORICUM 
    kali phosphoricum tablet
    Product Information
    Item Code (Source)NDC:15631-0612
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/10/2016
    Labeler - Rxhomeo Private Limited d.b.a. (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-2483) , label(15631-2483)