EPI Formula

Manufacturer
Nutritional Specialties, Inc.
Effective date
2024-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:27:13

Label at a glance#

ProductEPI Formula
Active ingredientATROPA BELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, OENANTHE CROCATA ROOT, CICUTA VIROSA ROOT, COPPER
Label structure9 sections

Dosage and administration

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Belladonna 4X, Hyoscyamus Niger 4X, Asterias Rubens 8X, Calcarea Carbonica 10X, Oenanthe Crocata 10X, Cicuta Virosa 12X, Cuprum Metallicum 12X.

PURPOSE:

OTC - PURPOSE SECTION

For the temporary relief of muscle spasms, twitches, stiffening and muscular weakness.†

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

WARNINGS:

WARNINGS SECTION

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of muscle spasms, twitches, stiffening and muscular weakness.†

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0139-1

EPI

FORMULA

2 FL. OZ (60 ml)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0139-1EPI Formula60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0139EPI FORMULA (BELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20240606_2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-013983027-0139-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUMNutritional Specialties, Inc.2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc2024-05-31WarningsExact identifier
ndc (package): 83027-0139-1
ndc (product): 83027-0139
ndc11 (package): 83027013901
spl id: 7b39c527-2c04-4a2b-9099-455505a8d26a
spl set id: 2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc

Reported adverse events (FAERS/openFDA)#

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