Drug Facts: - DailyMed Details

Drug Facts:

SPL v1

SPL

SPL Set ID 2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc

Route

ORAL

Published

Effective Date 2024-06-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Atropa Belladonna (4 [hp_X]) Hyoscyamus Niger (8 [hp_X]) Asterias Rubens (10 [hp_X]) Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Oenanthe Crocata Root Cicuta Virosa Root Copper

Inactive Ingredients

Water Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2024-05-31

Description

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

Purpose

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.

Medication Information

Purpose

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.

Description

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

Purpose:

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:

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

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

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:

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.

Active Ingredients:

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

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0139-1

EPI

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

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

Structured Label Content

Purpose: (PURPOSE:)

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:)

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

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Indications: (INDICATIONS:)

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.

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0139-1

EPI

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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

Advanced Ingredient Data

[{"name": "ATROPA BELLADONNA", "unii": "WQZ3G9PF0H", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "HYOSCYAMUS NIGER", "unii": "4WRK2153H3", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ASTERIAS RUBENS", "unii": "A7FYY9Q742", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "OENANTHE CROCATA ROOT", "unii": "6FS6FK5S8N", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CICUTA VIROSA ROOT", "unii": "YEA9P21S8N", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "COPPER", "unii": "789U1901C5", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE:": "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:": "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", "QUESTIONS:": "MANUFACTURED EXCLUSIVELY FOR NUTRITIONAL SPECIALTIES, INC. PO BOX 97227 PITTSBURG, PA 15229 www.phpltd.com", "DIRECTIONS:": "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:": "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.", "ACTIVE INGREDIENTS:": "Belladonna 4X, Hyoscyamus Niger 4X, Asterias Rubens 8X, Calcarea Carbonica 10X, Oenanthe Crocata 10X, Cicuta Virosa 12X, Cuprum Metallicum 12X.", "INACTIVE INGREDIENTS:": "Alcohol USP 20%, Purified Water USP.", "PACKAGE LABEL DISPLAY:": "Professional Health Products HOMEOPATHIC NDC 83027-0139-1 EPI FORMULA 2 FL. OZ (60 ml)", "KEEP OUT OF REACH OF CHILDREN:": "In case of overdose, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:11:30.765453 · Updated: 2026-03-14T23:16:55.652275