FDA.reportPublic FDA data

Gastrozen

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:19:28

Label at a glance#

ProductGastrozen
Active ingredientCOFFEA ARABICA SEED, ROASTED, GLYCYRRHIZA GLABRA, PHYTOLACCA AMERICANA ROOT, TARAXACUM OFFICINALE, GOLDENSEAL, ARSENIC TRIOXIDE, GELSEMIUM SEMPERVIRENS ROOT, MERCURIUS SOLUBILIS, NITRIC ACID, STRYCHNOS NUX-VOMICA SEED, KEROSENE, PHOSPHORIC ACID, PHOSPHORUS, BROMINE, CADMIUM SULFATE, CINCHONA OFFICINALIS BARK, CONIUM MACULATUM FLOWERING TOP, HYDROGEN, IODINE, LACHESIS MUTA VENOM, PULSATILLA VULGARIS WHOLE, SILICON DIOXIDE, SULFURIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Coffea Tosta 4X, Glycyrrhiza 4X, Phytolacca 4X, Taraxacum 4X, Hydrastis 6X, Arsenicum Alb 12X, Gelsemium 12X, Merc Solub 12X, Nitricum Ac 12X, Nux Vom 12X, Petroleum 12X, Phosphoricum Ac 12X, Phosphorus 12X, Bromium 30C, Cadmium Sulphuricum 30C, Cinchona 30C, Conium 30C, Hydrogen 30C, Iodium 30C, Lachesis 30C, Pulsatilla 30C, Silicea 30C, Sulphuricum Ac 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves minor abdominal cramps and bloating.**

OTC - PURPOSE SECTION

USES: Temporarily relieves minor abdominal cramps and bloating.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:43406-0690-1

Gastrozen

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0690-1Gastrozen30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0690GASTROZEN (COFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM AC) LIQUID [NATURAL CREATIONS, INC]1Current NDC, Legacy NDC, 1 package rows20230111_98dd756f-6774-47c3-bdfb-deff82fb801d.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-069043406-0690-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
COFFEA ARABICA SEED, ROASTED9H58JRT35EACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
GOLDENSEALZW3Z11D0JVACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
NITRIC ACID411VRN1TV4ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
KEROSENE1C89KKC04EACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
BROMINESBV4XY874GACTIB
CADMIUM SULFATE947UNF3Z6OACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
HYDROGEN7YNJ3PO35ZACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFURIC ACIDO40UQP6WCFACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
GastrozenCOFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM ACNatural Creations, Inc98dd756f-6774-47c3-bdfb-deff82fb801d2018-12-21WarningsExact identifier
ndc (package): 43406-0690-1
ndc (product): 43406-0690
ndc11 (package): 43406069001
spl id: 04d47b51-3874-4b44-b195-dec9fffa00ea
spl set id: 98dd756f-6774-47c3-bdfb-deff82fb801d

Reported adverse events (FAERS/openFDA)#

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