Gastritis - Ulcer

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:28

Label at a glance#

ProductGastritis - Ulcer
Active ingredientAntimony Trisulfide, Silver Nitrate, Arsenic Trioxide, Baptisia Tinctoria, Bismuth, Bryonia Alba Root, Cinchona Officinalis Bark, Citrullus Colocynthis Fruit Pulp, Graphite, Calcium Sulfide, Goldenseal, Ipecac, Potassium Dichromate, Potassium Carbonate, Lycopodium Clavatum Spore, Magnesium Carbonate, Magnesium Phosphate, Dibasic Trihydrate, Strychnos Nux-vomica Seed, Phosphorus, Podophyllum, 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

INDICATIONS & USAGE SECTION

Gastritis - Ulcer  Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona 15x, Colocynthis 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Ipecac. 15x, Kali bic. 15x, Kali carb.15x, Lycopodium 15x, Mag. carb. 15x, Mag. phos. 15x, Nux vom.15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Zingiber 15x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.

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.   

PREGNANCY OR BREAST FEEDING SECTION

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. 

KEEP OUT OF REACH OF CHILDREN SECTION

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
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4530-12020-01-31C16284748780-19d75b9d1-258c-f424-e053-dadaa90a57ceGastritis - Ulcer
55714-4530-22020-01-31C16284748780-19d75b9d1-258c-f424-e053-dadaa90a57ceGastritis - Ulcer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4530-1Gastritis - Ulcer29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4530-2Gastritis - Ulcer59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4530GASTRITIS - ULCER (ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA, COLOCYNTHIS, GRAPHITES, HEPAR SULPH. CALC., HYDRASTIS, IPECAC., KALI BIC., KALI CARB., LYCOPODIUM, MAG. CARB. MAG. PHOS., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, ZINGIBER, CHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA,TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.]3Legacy NDC, 2 package rows20140211_8e8f50c9-0609-1735-95bd-49dad6beaecb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U3
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO3
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y3
BismuthACTIVE INGREDIENTU015TT5I8H3
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B3
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q3
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB3
Citrullus Colocynthis Fruit PulpACTIVE INGREDIENT23H32AOH173
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX3
GingerACTIVE INGREDIENTC5529G5JPQ3
GoldensealACTIVE INGREDIENTZW3Z11D0JV3
GraphiteACTIVE INGREDIENT4QQN74LH4O3
IpecacACTIVE INGREDIENT62I3C8233L3
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC3
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4793
Magnesium CarbonateACTIVE INGREDIENT0E53J927NA3
Magnesium Phosphate, Dibasic TrihydrateACTIVE INGREDIENTHF539G9L3Q3
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ3
PhosphorusACTIVE INGREDIENT27YLU75U4W3
PodophyllumACTIVE INGREDIENT2S713A4VP33
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA3
Potassium DichromateACTIVE INGREDIENTT4423S18FM3
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV3
Ruta Graveolens Flowering TopACTIVE INGREDIENTN94C2U587S3
Silver NitrateACTIVE INGREDIENT95IT3W8JZE3
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139193
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3753
Antimony TrisulfideACTIVE MOIETYF79059A38U3
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV3
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y3
BismuthACTIVE MOIETYU015TT5I8H3
Bryonia Alba RootACTIVE MOIETYT7J046YI2B3
Calcium SulfideACTIVE MOIETY1MBW07J51Q3
Carbonate IonACTIVE MOIETY7UJQ5OPE7D3
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB3
Citrullus Colocynthis Fruit PulpACTIVE MOIETY23H32AOH173
Dichromate IonACTIVE MOIETY9LKY4BFN2V3
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX3
GingerACTIVE MOIETYC5529G5JPQ3
GoldensealACTIVE MOIETYZW3Z11D0JV3
GraphiteACTIVE MOIETY4QQN74LH4O3
IpecacACTIVE MOIETY62I3C8233L3
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC3
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4793
Magnesium CationACTIVE MOIETYT6V3LHY8383
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ3
PhosphorusACTIVE MOIETY27YLU75U4W3
PodophyllumACTIVE MOIETY2S713A4VP33
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV3
Ruta Graveolens Flowering TopACTIVE MOIETYN94C2U587S3
Silver CationACTIVE MOIETY57N7B0K90A3
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139193
Taraxacum OfficinaleACTIVE MOIETY39981FM3753
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-453055714-4530-1, 55714-4530-2

Ingredients#

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

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

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
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 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
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact 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
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact 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
6dd93b7b-88db-9c2b-af29-33bfd4c91a298e8f50c9-0609-1735-95bd-49dad6beaecb2011-06-01WarningsExact identifier
spl id: 6dd93b7b-88db-9c2b-af29-33bfd4c91a29
spl set id: 8e8f50c9-0609-1735-95bd-49dad6beaecb

Reported adverse events (FAERS/openFDA)#

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