FDA.reportPublic FDA data

Indigestion - Gas

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:45

Label at a glance#

ProductIndigestion - Gas
Active ingredientBismuth, Aloe, Angelica Sinensis Root, Antimony Trisulfide, Silver Nitrate, Arnica Montana, Arsenic Trioxide, Baptisia Tinctoria, Bryonia Alba Root, Cinchona Officinalis Bark, Graphite, Goldenseal, Ipecac, Lachesis Muta Venom, Lycopodium Clavatum Spore, Myrrh, Sodium Carbonate, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Ginger, Matricaria Recutita, Echinacea, Unspecified, Iris Versicolor Root, Ruta Graveolens Flowering Top, Taraxacum Officinale
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Indigestion - Gas  Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Bismuthum metallicum 15x, Aloe 10x, Angelica sinensis radix 10x, Antimon. crud. 10x, Arg. nit. 10x, Arnica 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Cinchona 10x, Graphites 10x, Hydrastis 10x, Ipecac. 10x, Lachesis 10x, Lycopodium 10x, Myrrha 10x, Nat. carb. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Zingiber 10x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with digestive discomfort such as acid reflux, belching, bloating, bad breath, heartburn, nausea and flatulence.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2238-02020-01-31C16284748780-19d75b9d0-6aa8-f424-e053-dadaa90a57ceIndigestion - Gas
55714-2238-12020-01-31C16284748780-19d75b9d0-6aa8-f424-e053-dadaa90a57ceIndigestion - Gas
55714-2238-22020-01-31C16284748780-19d75b9d0-6aa8-f424-e053-dadaa90a57ceIndigestion - Gas

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2238-0Indigestion - Gas.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2238-1Indigestion - Gas29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2238-2Indigestion - Gas59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2238INDIGESTION - GAS (BISMUTHUM METALLICUM, ALOE, ANGELICA SINENSIS RADIX, ANTIMON. CRUD., ARG. NIT., ARNICA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, GRAPHITES, HYDRASTIS, IPECAC., LACHESIS, LYCOPODIUM, MYRRHA, NAT. CARB., NUX VOM., PHOSPHORUS, PULSATILLA, ZINGIBER, CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA, TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130730_52c3f309-3a97-3258-2eca-19db83aa2c7c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AloeACTIVE INGREDIENTV5VD430YW92
Angelica Sinensis RootACTIVE INGREDIENTB66F4574UG2
Antimony TrisulfideACTIVE INGREDIENTF79059A38U2
Arnica MontanaACTIVE INGREDIENTO80TY208ZW2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y2
BismuthACTIVE INGREDIENTU015TT5I8H2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
GingerACTIVE INGREDIENTC5529G5JPQ2
GoldensealACTIVE INGREDIENTZW3Z11D0JV2
GraphiteACTIVE INGREDIENT4QQN74LH4O2
IpecacACTIVE INGREDIENT62I3C8233L2
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC2
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ2
MyrrhACTIVE INGREDIENTJC71GJ1F3L2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Ruta Graveolens Flowering TopACTIVE INGREDIENTN94C2U587S2
Silver NitrateACTIVE INGREDIENT95IT3W8JZE2
Sodium CarbonateACTIVE INGREDIENT45P3261C7T2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3752
AloeACTIVE MOIETYV5VD430YW92
Angelica Sinensis RootACTIVE MOIETYB66F4574UG2
Antimony TrisulfideACTIVE MOIETYF79059A38U2
Arnica MontanaACTIVE MOIETYO80TY208ZW2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y2
BismuthACTIVE MOIETYU015TT5I8H2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
GingerACTIVE MOIETYC5529G5JPQ2
GoldensealACTIVE MOIETYZW3Z11D0JV2
GraphiteACTIVE MOIETY4QQN74LH4O2
IpecacACTIVE MOIETY62I3C8233L2
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC2
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ2
MyrrhACTIVE MOIETYJC71GJ1F3L2
PhosphorusACTIVE MOIETY27YLU75U4W2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Ruta Graveolens Flowering TopACTIVE MOIETYN94C2U587S2
Silver CationACTIVE MOIETY57N7B0K90A2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Taraxacum OfficinaleACTIVE MOIETY39981FM3752
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-223855714-2238-1, 55714-2238-2, 55714-2238-0

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
BismuthU015TT5I8HACTIB
AloeV5VD430YW9ACTIB
Angelica Sinensis RootB66F4574UGACTIB
Antimony TrisulfideF79059A38UACTIB
Silver Nitrate95IT3W8JZEACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Baptisia Tinctoria5K1UO2888YACTIB
Bryonia Alba RootT7J046YI2BACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Graphite4QQN74LH4OACTIB
GoldensealZW3Z11D0JVACTIB
Ipecac62I3C8233LACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
MyrrhJC71GJ1F3LACTIB
Sodium Carbonate45P3261C7TACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
GingerC5529G5JPQACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Ruta Graveolens Flowering TopN94C2U587SACTIB
Taraxacum Officinale39981FM375ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
affa5226-f83d-dfe2-2376-3c87e69267d752c3f309-3a97-3258-2eca-19db83aa2c7c2011-03-01WarningsExact identifier
spl id: affa5226-f83d-dfe2-2376-3c87e69267d7
spl set id: 52c3f309-3a97-3258-2eca-19db83aa2c7c

Reported adverse events (FAERS/openFDA)#

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