Label: GUNA PAIN MANAGEMENT- achillea millefolium whole - bellis perennis whole - matricaria chamomilla whole - toxicodendron pubescens whole - ruta graveolens flowering top - comfrey root - apis mellifera - bryonia alba root - histamine hydrochloride - hypericum perforatum - kalmia latifolia leaf - arnica montana whole - pork liver - solution/ drops

  • 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 September 15, 2020

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  • INACTIVE INGREDIENT

    Inactive ingredient: Ethyl alcohol 30%.

  • QUESTIONS

    Questions?

    info@gunainc.com

    Tel. (484) 223-3500


  • WARNINGS

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Take 15 minutes before meals.

  • DIRECTIONS

    Take 15 minutes before meals.

    Adults and children twelve years and older: 20 drops in a little water, 2 times per day

    Children between 12 years and 6 years of age: 10 drops in a little water, 2 times per day

    Children under 6 years: consult a physician

  • PREGNANCY

    If pregnant or breast-feeding ask a health care profesisonal before use.

  • WARNINGS

    • Stop use and ask doctor if symptoms worsen or persist more than 5 days.
    • If pregnant or breast-feeding ask a health care professional before use.
    • Keep out of reach of children.
    • In case of accidental overdose, seek professional assistance or contact a poison control center immediately
    • Contains ethyl alcohol 30%


  • ACTIVE INGREDIENTS/PURPOSE

    Millefolium 2X Relieves pain

    Bellis perennis 2X Relieves muscle soreness, sprains

    Apis mellifica 30X Helps reduce swelling

    Bryonia 6X Relieves muscle and joint pain

    Chamomilla 2X Relieves inflammation

    Histaminum hydroc. 12X Relieves burning, redness

    Hepar suis 6X Relieves pain

    Hypericum perf. 3X Relieves pain

    Kalmia latifolia 6X Relieves pain

    Rhus tox 8X Relieves pain

    Ruta graveolens 4X Relieves pain

    Symphytum officinale 6X Relieves pain

    Arnica montana 3X Relieves inflammation

  • USES

    Relieves swelling and pain in cases of:

    • muscle aches, cramps
    • minor injuries, bruises
    • toothache
  • PRINCIPAL DISPLAY PANEL

    5USPAM

  • INGREDIENTS AND APPEARANCE
    GUNA PAIN MANAGEMENT 
    achillea millefolium whole - bellis perennis whole - matricaria chamomilla whole - toxicodendron pubescens whole - ruta graveolens flowering top - comfrey root - apis mellifera - bryonia alba root - histamine hydrochloride - hypericum perforatum - kalmia latifolia leaf - arnica montana whole - pork liver - solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-465
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 30 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [hp_X]  in 30 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 30 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE3 [hp_X]  in 30 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER6 [hp_X]  in 30 mL
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS WHOLE - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE2 [hp_X]  in 30 mL
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE2 [hp_X]  in 30 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF8 [hp_X]  in 30 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP4 [hp_X]  in 30 mL
    KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18) KALMIA LATIFOLIA LEAF6 [hp_X]  in 30 mL
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM WHOLE - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM WHOLE2 [hp_X]  in 30 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 30 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA30 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-465-181 in 1 BOX09/24/2020
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/24/2020
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-465)
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