E.n.v.

E.n.v.
SPL v1
SPL
SPL Set ID 838498ba-cab9-4e1b-a567-e7f1862b7fbb
Route
ORAL
Published
Effective Date 2023-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (30 [hp_C]) Berberis Vulgaris Root Bark Milk Thistle Chelidonium Majus Citrullus Colocynthis Fruit Pulp Dioscorea Villosa Root Goldenseal Lycopodium Clavatum Spore Sodium Sulfate Anhydrous Strychnos Nux-vomica Seed Phosphorus Anemone Pulsatilla Veratrum Album Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-12-08

Description

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


Medication Information

Warnings and Precautions

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.
Indications and Usage

USES: Temporarily relieves flatulence, constipation, and belching.**

Dosage and Administration

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

Description

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

Section 34093-5

*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.

Section 50565-1

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.

Section 51727-6

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

Section 51945-4

NDC:81825-0003-1

E.N.V.

(GBLV)

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

Zorex International LTD. / Lowell, MI 49331 / 800-679-3027

Section 55105-1

USES: Temporarily relieves flatulence, constipation, and belching.**

Section 55106-9

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


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves flatulence, constipation, and belching.**

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.
Section 34093-5 (34093-5)

*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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

Section 51945-4 (51945-4)

NDC:81825-0003-1

E.N.V.

(GBLV)

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Zorex International LTD. / Lowell, MI 49331 / 800-679-3027

Section 55105-1 (55105-1)

USES: Temporarily relieves flatulence, constipation, and belching.**

Section 55106-9 (55106-9)

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


Advanced Ingredient Data


Raw Label Data

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