FDA.reportPublic FDA data

Gas-Indigestion

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:54

Label at a glance#

ProductGas-Indigestion
Active ingredientMERCURY, STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, MAGNESIUM CARBONATE, RUTA GRAVEOLENS FLOWERING TOP, BAPTISIA TINCTORIA ROOT, TARAXACUM OFFICINALE, ANTIMONY TRISULFIDE, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, COLCHICUM AUTUMNALE BULB, DAPHNE ODORA BARK, IPECAC, IRIS VERSICOLOR ROOT, POTASSIUM CARBONATE, WOOD CREOSOTE, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, ECHINACEA, UNSPECIFIED, RANCID BEEF, PHOSPHORUS, ANEMONE PULSATILLA, SPIGELIA ANTHELMIA, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as bloating, nausea, eructations and pain or burning sensation in the upper abdomen.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, Iris versicolor 6x, Ruta graveolens 6x, Taraxacum officinale 6x, Antimonium crudum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bryonia 15x, Carbo vegetabilis 15x, Chelidonium majus 15x, Cinchona officinalis 15x, Colchicum autumnale 15x, Daphne indica 15x, Ipecacuanha 15x, Iris versicolor 15x, Kali carbonicum 15x, Kreosotum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Spigelia anthelmia 15x, Sulphur 15x, Pyrogenium 30x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as bloating, nausea, eructations and pain or burning sensation in the upper abdomen

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4809-1Gas-Indigestion30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4809GAS-INDIGESTION (CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUM) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20250212_9a125a53-39c2-d849-e053-2a95a90a9845.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
55714-480955714-4809-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
MERCURYFXS1BY2PGLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
DAPHNE ODORA BARKJSJ34YQJ5DACTIB
IPECAC62I3C8233LACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
RANCID BEEF29SUH5R3HUACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
SULFUR70FD1KFU70ACTIB

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
Gas-IndigestionCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, DAPHNE INDICA, IPECACUANHA, IRIS VERSICOLOR, KALI CARBONICUM, KREOSOTUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS, PULSATILLA, SPIGELIA ANTHELMIA, SULPHUR, PYROGENIUMNewton Laboratories, Inc.9a125a53-39c2-d849-e053-2a95a90a98452025-02-10WarningsExact identifier
ndc (package): 55714-4809-1
ndc (product): 55714-4809
ndc11 (package): 55714480901
spl id: 2dd20422-cc1f-36f4-e063-6394a90aeb64
spl set id: 9a125a53-39c2-d849-e053-2a95a90a9845

Reported adverse events (FAERS/openFDA)#

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