Label: SEVERE HEMORRHOIDS REAL RELIEF- paeonia officinalis, ratanhia, nitricum acidum, sulfur, podophyllum peltatum, ruta graveolens, graphites, apis mellifica, aesculus hippocastanum, nux vomica tablet, chewable

  • 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 November 21, 2012

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  • ACTIVE INGREDIENTS HPUS

    Paeonia officinalis (Peony) 8X
    Ratanhia (Rhatany) 8X
    Nitricum acidum (Nitric acid) 8X
    Sulphur (Sublimed sulfur) 8X
    Podophyllum peltatum (Mayapple) 8X
    Ruta graveolens (Rue) 8X
    Graphites (Plumbago) 8X
    Apis mellifica (Honeybee) 8X
    Aesculus hippocastanum (Horse chesnut) 8X
    Nux vomica (Poison nut) 8X


  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    hemorrhoids with ulceration
    rectal pain, irritation
    painless or burning hemorrhoids
    inflammation, swollen tissue
    external/internal discomfort, irritation
    rectal pain
    painful burning tissue with fissures
    swollen rectal tissue
    painful hemorrhoids
    itching and bleeding hemorrhoids
  • USES

    This homeopathic medicine helps relieve hemorrhoidal symptoms:

    - external/internal discomfort

    - swollen tissue

    - irritation

  • WARNINGS


    Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • DIRECTIONS

    Chew tablets and let dissolve in mouth.

    Do not use more than directed.

    Do not take with food.

    Repeat 3 times daily and reduce with improvement or as directed by a health professional.


    Age
    		 Dose
    Adults and children 12 years of age and older2 tablets
    Children 2 to 11 years of age1 tablet
    Children under 2 years of ageAsk a doctor
  • OTHER INFORMATION

    Store at room temperature (68 - 77F).

    Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.


  • CARTON

    image description

  • INGREDIENTS AND APPEARANCE
    SEVERE HEMORRHOIDS  REAL RELIEF
    paeonia officinalis, ratanhia, nitricum acidum, sulfur, podophyllum peltatum, ruta graveolens, graphites, apis mellifica, aesculus hippocastanum, nux vomica tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6038
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT8 [hp_X]
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT8 [hp_X]
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID8 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM8 [hp_X]
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP8 [hp_X]
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE8 [hp_X]
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA8 [hp_X]
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT8 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6038-090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/25/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-6038)
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