FDA.reportPublic FDA data

Tummy Upset

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:49

Label at a glance#

ProductTummy Upset
Active ingredientLYCOPODIUM CLAVATUM SPORE, MYRRH, MATRICARIA CHAMOMILLA, SODIUM CARBONATE, IRIS VERSICOLOR ROOT, RUTA GRAVEOLENS FLOWERING TOP, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS ROOT, ANTIMONY TRISULFIDE, SILVER NITRATE, ARNICA MONTANA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, BISMUTH, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, GRAPHITE, GOLDENSEAL, IPECAC, LACHESIS MUTA VENOM, PHOSPHORUS, ANEMONE PULSATILLA, GINGER, STRYCHNOS NUX-VOMICA SEED, ECHINACEA, UNSPECIFIED
Label structure10 sections

Label contents#

Full prescribing information#

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

OTC - 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.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1731-1Tummy Upset28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1731TUMMY 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.]2Current NDC, Legacy NDC, 1 package rows20250209_9dc307a2-4aa1-b02a-e053-2995a90a1788.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-173155714-1731-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MYRRHJC71GJ1F3LACTIB
SUCROSEC151H8M554IACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
SODIUM CARBONATE45P3261C7TACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
ALOEV5VD430YW9ACTIB
ANGELICA SINENSIS ROOTB66F4574UGACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA5K1UO2888YACTIB
BISMUTHU015TT5I8HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
GRAPHITE4QQN74LH4OACTIB
GOLDENSEALZW3Z11D0JVACTIB
IPECAC62I3C8233LACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
GINGERC5529G5JPQACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tummy UpsetCHAMOMILLA, 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.Newton Laboratories, Inc.9dc307a2-4aa1-b02a-e053-2995a90a17882025-02-06WarningsExact identifier
ndc (package): 55714-1731-1
ndc (product): 55714-1731
ndc11 (package): 55714173101
spl id: 2d813d91-7ac9-7366-e063-6294a90ad6c2
spl set id: 9dc307a2-4aa1-b02a-e053-2995a90a1788

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.