MedPath

Indigestion-Gas

Indigestion 2466P

Approved
Approval ID

9c1cd511-64d4-3607-e053-2995a90a6029

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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.

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-2466
Product Classification
G
Generic Name
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.
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (27)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
MATRICARIA CHAMOMILLAActive
Quantity: 6 [hp_X] in 1 g
Code: G0R4UBI2ZZ
Classification: ACTIB
SODIUM CARBONATEActive
Quantity: 15 [hp_X] in 1 g
Code: 45P3261C7T
Classification: ACTIB
IRIS VERSICOLOR ROOTActive
Quantity: 6 [hp_X] in 1 g
Code: X43D4L3DQC
Classification: ACTIB
RUTA GRAVEOLENS FLOWERING TOPActive
Quantity: 6 [hp_X] in 1 g
Code: N94C2U587S
Classification: ACTIB
TARAXACUM OFFICINALEActive
Quantity: 6 [hp_X] in 1 g
Code: 39981FM375
Classification: ACTIB
ALOEActive
Quantity: 15 [hp_X] in 1 g
Code: V5VD430YW9
Classification: ACTIB
ANGELICA SINENSIS ROOTActive
Quantity: 15 [hp_X] in 1 g
Code: B66F4574UG
Classification: ACTIB
ANTIMONY TRISULFIDEActive
Quantity: 15 [hp_X] in 1 g
Code: F79059A38U
Classification: ACTIB
SILVER NITRATEActive
Quantity: 15 [hp_X] in 1 g
Code: 95IT3W8JZE
Classification: ACTIB
ARNICA MONTANAActive
Quantity: 15 [hp_X] in 1 g
Code: O80TY208ZW
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 15 [hp_X] in 1 g
Code: S7V92P67HO
Classification: ACTIB
BAPTISIA TINCTORIAActive
Quantity: 15 [hp_X] in 1 g
Code: 5K1UO2888Y
Classification: ACTIB
BISMUTHActive
Quantity: 15 [hp_X] in 1 g
Code: U015TT5I8H
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 15 [hp_X] in 1 g
Code: T7J046YI2B
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 15 [hp_X] in 1 g
Code: S003A158SB
Classification: ACTIB
GRAPHITEActive
Quantity: 15 [hp_X] in 1 g
Code: 4QQN74LH4O
Classification: ACTIB
GOLDENSEALActive
Quantity: 15 [hp_X] in 1 g
Code: ZW3Z11D0JV
Classification: ACTIB
IPECACActive
Quantity: 15 [hp_X] in 1 g
Code: 62I3C8233L
Classification: ACTIB
LACHESIS MUTA VENOMActive
Quantity: 15 [hp_X] in 1 g
Code: VSW71SS07I
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 15 [hp_X] in 1 g
Code: C88X29Y479
Classification: ACTIB
MYRRHActive
Quantity: 15 [hp_X] in 1 g
Code: JC71GJ1F3L
Classification: ACTIB
PHOSPHORUSActive
Quantity: 15 [hp_X] in 1 g
Code: 27YLU75U4W
Classification: ACTIB
ANEMONE PULSATILLAActive
Quantity: 15 [hp_X] in 1 g
Code: I76KB35JEV
Classification: ACTIB
GINGERActive
Quantity: 15 [hp_X] in 1 g
Code: C5529G5JPQ
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 15 [hp_X] in 1 g
Code: 269XH13919
Classification: ACTIB
ECHINACEA, UNSPECIFIEDActive
Quantity: 6 [hp_X] in 1 g
Code: 4N9P6CC1DX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

PACKAGE LABEL

Package label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as belching, bloating, bad breath, nausea, heartburn and flatulence.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2019

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2019

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

LOINC: 55105-1Updated: 8/20/2025

OTC - PURPOSE SECTION

Formulated for associated symptoms such as belching, bloating, bad breath, nausea, heartburn and flatulence.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2019

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2019

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2019

WARNINGS SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 1/1/2019

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2019

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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