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#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Gastritis - Ulcer Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.
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
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
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
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
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
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4530-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-258c-f424-e053-dadaa90a57ce | Gastritis - Ulcer |
| 55714-4530-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-258c-f424-e053-dadaa90a57ce | Gastritis - Ulcer |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4530-1 | Gastritis - Ulcer | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 3 | |
| 55714-4530-2 | Gastritis - Ulcer | 59.14 mL in 1 BOTTLE, GLASS | LIQUID | 59.14 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4530 | GASTRITIS - 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.] | 3 | Legacy NDC, 2 package rows | 20140211_8e8f50c9-0609-1735-95bd-49dad6beaecb.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Antimony Trisulfide | ACTIVE INGREDIENT | F79059A38U | 3 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 3 | |
| Baptisia Tinctoria | ACTIVE INGREDIENT | 5K1UO2888Y | 3 | |
| Bismuth | ACTIVE INGREDIENT | U015TT5I8H | 3 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 3 | |
| Calcium Sulfide | ACTIVE INGREDIENT | 1MBW07J51Q | 3 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 3 | |
| Citrullus Colocynthis Fruit Pulp | ACTIVE INGREDIENT | 23H32AOH17 | 3 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 3 | |
| Ginger | ACTIVE INGREDIENT | C5529G5JPQ | 3 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 3 | |
| Graphite | ACTIVE INGREDIENT | 4QQN74LH4O | 3 | |
| Ipecac | ACTIVE INGREDIENT | 62I3C8233L | 3 | |
| Iris Versicolor Root | ACTIVE INGREDIENT | X43D4L3DQC | 3 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 3 | |
| Magnesium Carbonate | ACTIVE INGREDIENT | 0E53J927NA | 3 | |
| Magnesium Phosphate, Dibasic Trihydrate | ACTIVE INGREDIENT | HF539G9L3Q | 3 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 3 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 3 | |
| Podophyllum | ACTIVE INGREDIENT | 2S713A4VP3 | 3 | |
| Potassium Carbonate | ACTIVE INGREDIENT | BQN1B9B9HA | 3 | |
| Potassium Dichromate | ACTIVE INGREDIENT | T4423S18FM | 3 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 3 | |
| Ruta Graveolens Flowering Top | ACTIVE INGREDIENT | N94C2U587S | 3 | |
| Silver Nitrate | ACTIVE INGREDIENT | 95IT3W8JZE | 3 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 3 | |
| Taraxacum Officinale | ACTIVE INGREDIENT | 39981FM375 | 3 | |
| Antimony Trisulfide | ACTIVE MOIETY | F79059A38U | 3 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 3 | |
| Baptisia Tinctoria | ACTIVE MOIETY | 5K1UO2888Y | 3 | |
| Bismuth | ACTIVE MOIETY | U015TT5I8H | 3 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 3 | |
| Calcium Sulfide | ACTIVE MOIETY | 1MBW07J51Q | 3 | |
| Carbonate Ion | ACTIVE MOIETY | 7UJQ5OPE7D | 3 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 3 | |
| Citrullus Colocynthis Fruit Pulp | ACTIVE MOIETY | 23H32AOH17 | 3 | |
| Dichromate Ion | ACTIVE MOIETY | 9LKY4BFN2V | 3 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 3 | |
| Ginger | ACTIVE MOIETY | C5529G5JPQ | 3 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 3 | |
| Graphite | ACTIVE MOIETY | 4QQN74LH4O | 3 | |
| Ipecac | ACTIVE MOIETY | 62I3C8233L | 3 | |
| Iris Versicolor Root | ACTIVE MOIETY | X43D4L3DQC | 3 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 3 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 3 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 3 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 3 | |
| Podophyllum | ACTIVE MOIETY | 2S713A4VP3 | 3 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 3 | |
| Ruta Graveolens Flowering Top | ACTIVE MOIETY | N94C2U587S | 3 | |
| Silver Cation | ACTIVE MOIETY | 57N7B0K90A | 3 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 3 | |
| Taraxacum Officinale | ACTIVE MOIETY | 39981FM375 | 3 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 3 |
Products#
Every source-derived product name is available through these pages.
- Gastritis - 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
- Antimony Trisulfide
- Silver Nitrate
- Silver Cation
- Arsenic Trioxide
- Arsenic Cation (3+)
- Baptisia Tinctoria
- Bismuth
- Bryonia Alba Root
- Cinchona Officinalis Bark
- Citrullus Colocynthis Fruit Pulp
- Graphite
- Calcium Sulfide
- Goldenseal
- Ipecac
- Potassium Dichromate
- Dichromate Ion
- Potassium Carbonate
- Carbonate Ion
- Lycopodium Clavatum Spore
- Magnesium Carbonate
- Magnesium Phosphate, Dibasic Trihydrate
- Magnesium Cation
- Strychnos Nux-vomica Seed
- Phosphorus
- Podophyllum
- Pulsatilla Vulgaris
- Ginger
- Matricaria Recutita
- Echinacea, Unspecified
- Iris Versicolor Root
- Ruta Graveolens Flowering Top
- Taraxacum Officinale
- Alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4530 | 55714-4530-1, 55714-4530-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6dd93b7b-88db-9c2b-af29-33bfd4c91a29 | 8e8f50c9-0609-1735-95bd-49dad6beaecb | 2011-06-01 | Warnings | 6dd93b7b-88db-9c2b-af29-33bfd4c91a29 8e8f50c9-0609-1735-95bd-49dad6beaecb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
