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 
Newton Laboratories, Inc.

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.

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Tummy 1731P

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as nausea, "spitting up," vomiting, cramping, pain and gas.

DOSAGE & ADMINISTRATION SECTION

Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.

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

Formulated for associated symptoms such as nausea, "spitting up," vomiting, cramping, pain and gas.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1731
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 g
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE15 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]  in 1 g
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE6 [hp_X]  in 1 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE15 [hp_X]  in 1 g
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT15 [hp_X]  in 1 g
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY TRISULFIDE15 [hp_X]  in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE15 [hp_X]  in 1 g
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 g
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y) BAPTISIA TINCTORIA15 [hp_X]  in 1 g
BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE15 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 g
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 g
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 g
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH15 [hp_X]  in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 g
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 g
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-1731-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-1731)

Revised: 2/2020
Document Id: 9dc3059c-3a3c-5810-e053-2a95a90ab0ba
Set id: 9dc307a2-4aa1-b02a-e053-2995a90a1788
Version: 1
Effective Time: 20200204
 
Newton Laboratories, Inc.