FDA.reportPublic FDA data

Tummy Upset

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:40

Label at a glance#

ProductTummy Upset
Active ingredientMATRICARIA 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, LYCOPODIUM CLAVATUM SPORE, MYRRH, PHOSPHORUS, ANEMONE PULSATILLA, GINGER, STRYCHNOS NUX-VOMICA SEED, ECHINACEA, UNSPECIFIED
Label structure9 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 drops by mouth (ages 12 and up, give 6 drops) as needed or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

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
55714-1531-1Tummy Upset30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1531TUMMY 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.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250130_9dc2da0a-0b3a-548e-e053-2995a90abe6d.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-153155714-1531-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MYRRHJC71GJ1F3LACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
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.9dc2da0a-0b3a-548e-e053-2995a90abe6d2025-01-28WarningsExact identifier
ndc (package): 55714-1531-1
ndc (product): 55714-1531
ndc11 (package): 55714153101
spl id: 2cc873e9-56d3-47d6-e063-6394a90a3b84
spl set id: 9dc2da0a-0b3a-548e-e053-2995a90abe6d

Reported adverse events (FAERS/openFDA)#

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