Label: GUNA STOMACH PLUS- antimonium crudum - argentum nitricum - arsenicum album - ipecacuanha - nux vomica - origanum majorana - cuprum metallicum - taraxacum officinale - natrum phosphoricum - pellet

  • NDC Code(s): 17089-477-20, 17089-477-21
  • 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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  • ACTIVE INGREDIENTS/PURPOSE

    Antimonium crudum 6X Relieves heartburn

    Argentum nitricum 6X Relieves heartburn

    Arsenicum album 6X Relieves indigestion and nausea

    Ipecacuanha 8X, 30X, 200X Relieves nausea and vomiting

    Nux vomica 4X Relieves heartburn, stomach pain

    Origanum majorana 6X Loss of appetite, hiccough

    Cuprum metallicum 4X Relieves stomach cramps

    Taraxacum officinale 6X Relieves heartburn, sour stomach

    Natrum phosphoricum 4X Relieves heartburn, sour stomach

  • 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.
  • USES

    Relieves symptoms of acid reflux and gastritis such as:

    • heartburn
    • sour stomach
    • nausea after eating
  • INDICATIONS & USAGE

    Relieves symptoms of acid reflux and gastritis such as:

    • heartburn
    • sour stomach
    • nausea after eating
  • QUESTIONS

    Questions?

    info@gunainc.com



    (484) 223-3500

  • 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 health care professional before use
    • keep out of reach of children
  • 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.
  • DOSAGE & ADMINISTRATION

    • Adults and children 12 years and older 5 pellets 3 times per day
    • Children between 12 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
  • INACTIVE INGREDIENT

    Inactive ingredient: Sucrose.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children
  • PRINCIPAL DISPLAY PANEL

    5USSP15USSTP-2

  • INGREDIENTS AND APPEARANCE
    GUNA STOMACH PLUS 
    antimonium crudum - argentum nitricum - arsenicum album - ipecacuanha - nux vomica - origanum majorana - cuprum metallicum - taraxacum officinale - natrum phosphoricum - pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-477
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED4 [hp_X]  in 4 g
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE6 [hp_X]  in 4 g
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER4 [hp_X]  in 4 g
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC8 [hp_X]  in 4 g
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE6 [hp_X]  in 4 g
    ORIGANUM MAJORANA (UNII: R40XM3HU5X) (ORIGANUM MAJORANA - UNII:R40XM3HU5X) ORIGANUM MAJORANA6 [hp_X]  in 4 g
    TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) (TARAXACUM OFFICINALE ROOT - UNII:9DE5YCO0RU) TARAXACUM OFFICINALE ROOT6 [hp_X]  in 4 g
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE4 [hp_X]  in 4 g
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [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:17089-477-202 in 1 BOX02/17/2021
    14 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:17089-477-211 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 homeopathic02/17/2021
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-477)
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