Label: RXHOMEO HOMEOPATHIC COMBO 13 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 23, 2016

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

  • ACTIVE INGREDIENT

    HELLEBORUS NIGER HPUS 3X and higher

    KALI PHOSPHORICUM HPUS 1X and higher

  • USES

    A homeopathic combination pack with two single remedies Helleborus Niger and Kali Phosphoricum for relief of symptoms associated with depression.

    Helleborus Niger: Helleborus Niger is a chief remedy for treating depression. The patient is very much irritable and easily angered. He does not want to be disturbed. The patient is very much melancholic, woeful, despairing, silent or extremely anguished. It is especially suitable to girls at puberty or when menses fail to return after appearing. The patient is worse from consolation. Helleborus Niger is also suitable for many brain troubles during dentition with threatned effusion. Also unconscious and stupid when questioned and answers slowly. Helleborus Niger also helps in homesickness.

    Kali Phos: Kali Pho is a suitable remedy depression. The patient is very nervous, depressed and general irritability. There is great despondency about business and loss of memory. Indisposition to meet people. The patient is shy with no inclination to converse. Want of energy, slightest labour seems heavy task. Also brain fag from over work. Anxiety and nervousness. Gloomy and always looks at the dark side of everything. There is extreme lassitude and depression. There are hallucinations and illusions of senses. Also helps in anemic conditions.

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE

    Adults: Take 4-5 pellets or tablets orally by mouth and allow them to dissolve on tongue. Repeat at least 3 times a day, about 30 minutes before or after food. Similarly take the second remedy after a gap of 30 minutes, make sure to remember the sequence.

    Children: Half of 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 13 
    rxhomeo homeopathic combo 13 kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2463
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-2463-01 in 1 CONTAINER10/22/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    HELLEBORUS NIGER 
    helleborus niger pellet
    Product Information
    Item Code (Source)NDC:15631-0221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT3 [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 homeopathic10/22/2016
    Labeler - Rxhomeo Private Limited d.b.a. (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a.,Rxhomeo, Inc650833994manufacture(15631-2463) , label(15631-2463)