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  5. Label Information: E.n.v.

FDA Label for E.n.v.

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - PURPOSE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

E.n.v. Product Label

The following document was submitted to the FDA by the labeler of this product Zorex International. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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



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


Otc - Purpose



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


Dosage & Administration



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



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



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



INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water


Otc - Questions



QUESTIONS & COMMENTS?

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


References



*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

image description - E.N.V

image description - E.N.V


* Please review the disclaimer below.