Label: TUMMY UPSET- chamomilla, echinacea, iris versicolor, ruta graveolens, taraxacum officinale, aloe, angelica sinensis radix, antimonium , argentum nitricum, arnica montana, arsenicum album, baptisia tinctoria, bismuthum metallicum, bryonia, cinchona officinalis, graphites, hydrastis canadensis, ipecacuanha, lachesis mutus, lycopodium clavatum, myrrha, natrum carbonicum, nux vomica, phosphorus, pulsatilla, zingiber officinale. pellet
- NDC Code(s): 55714-1731-1
- Packager: Newton Laboratories, Inc.
- 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 February 4, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Chamomilla 6x, Echinacea 6x, Iris versicolor 6x, Ruta graveolens 6x, Taraxacum officinale 6x, Aloe 15x, Angelica sinensis radix 15x, Antimonium crudum 15x, Argentum nitricum 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona officinalis 15x, Graphites 15x, Hydrastis canadensis 15x, Ipecacuanha 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Myrrha 15x, Natrum carbonicum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Zingiber officinale 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
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- OTC - PREGNANCY OR BREAST FEEDING SECTION
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INGREDIENTS AND APPEARANCE
TUMMY UPSET
chamomilla, echinacea, iris versicolor, ruta graveolens, taraxacum officinale, aloe, angelica sinensis radix, antimonium , argentum nitricum, arnica montana, arsenicum album, baptisia tinctoria, bismuthum metallicum, bryonia, cinchona officinalis, graphites, hydrastis canadensis, ipecacuanha, lachesis mutus, lycopodium clavatum, myrrha, natrum carbonicum, nux vomica, phosphorus, pulsatilla, zingiber officinale. pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1731 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 g SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 15 [hp_X] in 1 g IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 6 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 g TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 6 [hp_X] in 1 g ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 15 [hp_X] in 1 g ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT 15 [hp_X] in 1 g ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY TRISULFIDE 15 [hp_X] in 1 g SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 15 [hp_X] in 1 g ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 15 [hp_X] in 1 g ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 g BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA 15 [hp_X] in 1 g BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH 15 [hp_X] in 1 g BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 g CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 g GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 15 [hp_X] in 1 g GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 15 [hp_X] in 1 g IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 15 [hp_X] in 1 g LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 15 [hp_X] in 1 g LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 g MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH 15 [hp_X] in 1 g PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 15 [hp_X] in 1 g ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 15 [hp_X] in 1 g GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 15 [hp_X] in 1 g STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-1731-1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-1731)
