Label: GUNA DEFENSE- calcium sulfide - centella asiatica - echinacea angustifolia whole - echinacea purpurea - thuja occidentalis leafy twig - vincetoxicum hirundinaria root - phytolacca americana root - sulfur - pellet

  • NDC Code(s): 17089-467-20, 17089-467-21
  • Packager: Guna spa
  • 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 December 15, 2021

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  • INDICATIONS & USAGE

    Uses:

    Relieves respiratory or intestinal symptoms of viral infections, such as: cough, sore throat; cold sores; fever; diarrhea

  • INACTIVE INGREDIENT

    Inactive ingredient: Sucrose.

  • DOSAGE & ADMINISTRATION

    • Adults and children 12 years and older 5 pellets 3 times per day
    • Children between 12 years and 6 years of age 3 pellets 3 times per day
    • Children under 6 years 1 pellet 3 times per day to be disoolved into a little water
  • QUESTIONS

    Questions?

    info@gunainc.com

    (484) 223-3500

  • DIRECTIONS

    • Turn tube upside down and rotate cap to release pellets into cap.
    • Unscrew cap and, without touching the pellets, place them under the tongue.
    • Allow to dissolve.
    • Take 15 minutes before meals.
  • WARNINGS

    Keep out of reach of children

  • PREGNANCY

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

  • WARNINGS

    • Stop use and ask doctor if symptoms persist more than 5 days or worsen.
    • If pregnant or breast-feeding ask a helath care professional before use
    • keep out of reach of children
  • USES

    Relieves respiratory or intestinal symptoms of viral infections, such as:

    • cough, sore throat
    • cold sores
    • fever
    • diarrhea
  • ACTIVE INGREDIENTS/PURPOSE

    Asclepias vincetoxicum 6X Relieves fever of viral origin

    Echinacea 2X Relieves cold symptoms

    Echinacea purpurea 2X Relieves cold symptoms

    Hepar sulphuris calc. 10X Relieves painful, dry cough

    Hydrocotyle asiatica 4X Relieves sore throat

    Phytolacca decandra 4X Relieves sore throat

    Sulphur 10X Relieves diarrhea

    Thuja occidentalis 6X Relieves cold sores

  • WARNINGS

    • Stop use and ask doctor if symptoms persist more than 5 days or worsen.
    • If pregnant or breast-feeding ask a health professional before use.
    • Keep out of reach of children.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children
  • PRINCIPAL DISPLAY PANEL

    5USDF15USEDF-GUNA DEFENSE-Rev04-22-09-205USDEF

  • INGREDIENTS AND APPEARANCE
    GUNA DEFENSE 
    calcium sulfide - centella asiatica - echinacea angustifolia whole - echinacea purpurea - thuja occidentalis leafy twig - vincetoxicum hirundinaria root - phytolacca americana root - sulfur - pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-467
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA4 [hp_X]  in 4 g
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE2 [hp_X]  in 4 g
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]  in 4 g
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE10 [hp_X]  in 4 g
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 4 g
    VINCETOXICUM HIRUNDINARIA ROOT (UNII: 9R858U917W) (VINCETOXICUM HIRUNDINARIA ROOT - UNII:9R858U917W) VINCETOXICUM HIRUNDINARIA ROOT6 [hp_X]  in 4 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT4 [hp_X]  in 4 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554) 4 g  in 4 g
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-467-202 in 1 BOX09/24/2020
    14 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:17089-467-211 in 1 BOX12/15/2021
    24 g in 1 TUBE; 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(17089-467)
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