ATROPA BELLADONNA
- Manufacturer
- Zorex International | OHM Pharma, Inc
- Effective date
- 2018-12-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:20:59
Label at a glance#
ProductE.N.V.
Active ingredientATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, MILK THISTLE, CHELIDONIUM MAJUS WHOLE, CITRULLUS COLOCYNTHIS FRUIT PULP, DIOSCOREA VILLOSA TUBER, GOLDENSEAL, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, VERATRUM ALBUM ROOT
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS (HPUS*): equal amounts of: Belladonna 30C, Berberis Vulg 30C, Carduus Mar 30C, Chelidonium Maj 30C, Colocynthis 30C, Dioscorea 30C, Hydrastis 30C, Lycopodium 30C, Nat Sulphuricum 30C, Nux Vom 30C, Phos 30C, Pulsatilla 30C, Veratrum Alb 30C
INDICATIONS & USAGE SECTION
USES: Temporarily relieves flatulence, constipation, and belching.**
OTC - PURPOSE SECTION
USES: Temporarily relieves flatulence, constipation, and belching.**
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?
Zorex International LTD. / Lowell, MI 49331 / 800-679-3027
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:81825-0003-1
E.N.V.
(GBLV)
HOMEOPATHIC
1 fl oz (30mL) / 20% Alcohol
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 95250459-30e4-45c1-b08a-993044f49109 | Product name | 2 | 20250805 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 9badc7be-250a-44ab-aa36-926af3f02679 | Product name | 1 | 20210527 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 26acd337-b838-40ac-bcbc-05c3b81c8712 | Product name | 1 | 20170323 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81825-0003-1 | E.N.V. | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81825-0003 | E.N.V. (BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALB) LIQUID [ZOREX INTERNATIONAL] | 1 | Current NDC, 1 package rows | 20230422_838498ba-cab9-4e1b-a567-e7f1862b7fbb.zip |
Products#
Every source-derived product name is available through these pages.
- E.N.V.
- Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb
- ATROPA BELLADONNA
- BERBERIS VULGARIS ROOT BARK
- MILK THISTLE
- CHELIDONIUM MAJUS WHOLE
- CHELIDONIUM MAJUS
- CITRULLUS COLOCYNTHIS FRUIT PULP
- DIOSCOREA VILLOSA TUBER
- DIOSCOREA VILLOSA ROOT
- GOLDENSEAL
- LYCOPODIUM CLAVATUM SPORE
- SODIUM SULFATE
- SODIUM SULFATE ANHYDROUS
- STRYCHNOS NUX-VOMICA SEED
- PHOSPHORUS
- PULSATILLA VULGARIS WHOLE
- ANEMONE PULSATILLA
- VERATRUM ALBUM ROOT
- ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81825-0003 | 81825-0003-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| BERBERIS VULGARIS ROOT BARK | 1TH8Q20J0U | ACTIB |
| MILK THISTLE | U946SH95EE | ACTIB |
| CHELIDONIUM MAJUS WHOLE | 7E889U5RNN | ACTIB |
| CITRULLUS COLOCYNTHIS FRUIT PULP | 23H32AOH17 | ACTIB |
| DIOSCOREA VILLOSA TUBER | IWY3IWX2G8 | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| LYCOPODIUM CLAVATUM SPORE | C88X29Y479 | ACTIB |
| SODIUM SULFATE | 0YPR65R21J | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| PULSATILLA VULGARIS WHOLE | I76KB35JEV | ACTIB |
| VERATRUM ALBUM ROOT | QNS6W5US1Z | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| E.N.V. | BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALB | Zorex International | 838498ba-cab9-4e1b-a567-e7f1862b7fbb | 2018-12-21 | Warnings | 81825-0003-1 81825-0003 81825000301 70783c3e-4437-477e-8a45-0345fbcf573a 838498ba-cab9-4e1b-a567-e7f1862b7fbb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.