Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID e476127e-105e-4e5c-8d94-147dd97c9288
Route
ORAL
Published
Effective Date 2023-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera (6 [hp_X]) Citrus Aurantium Fruit Rind (12 [hp_X]) Clematis Vitalba Flower (16 [hp_X]) Bos Taurus Adrenal Gland Helianthemum Nummularium Flower Impatiens Glandulifera Flower Phosphate Ion Ornithogalum Umbellatum Flowering Top Prunus Cerasifera Flower Scutellaria Lateriflora Whole Viburnum Opulus Bark Cortisone Aconitum Napellus Epinephrine Dopamine
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-25

Description

Apis Mellifica 6X, Citrus Vulgaris 6X, Clematis Vitalba, Flos 6X, Glandula Suprarenalis (Adrenal) 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Kali Phosphoricum 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Scutellaria Lateriflora 6X, Viburnum Opulus 6X, Cortisone Aceticum 6X, 12X, Aconitum Napellus 12X, Adrenalinum 12X, Dopamine 16X, 30X.

Purpose

Aids in stimulation of rejuvenating and relaxing mechanisms.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in stimulation of rejuvenating and relaxing mechanisms.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Apis Mellifica 6X, Citrus Vulgaris 6X, Clematis Vitalba, Flos 6X, Glandula Suprarenalis (Adrenal) 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Kali Phosphoricum 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Scutellaria Lateriflora 6X, Viburnum Opulus 6X, Cortisone Aceticum 6X, 12X, Aconitum Napellus 12X, Adrenalinum 12X, Dopamine 16X, 30X.

Purpose:

Aids in stimulation of rejuvenating and relaxing mechanisms.†

†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:

Aids in stimulation of rejuvenating and relaxing mechanisms.†

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

Active Ingredients:

Apis Mellifica 6X, Citrus Vulgaris 6X, Clematis Vitalba, Flos 6X, Glandula Suprarenalis (Adrenal) 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Kali Phosphoricum 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Scutellaria Lateriflora 6X, Viburnum Opulus 6X, Cortisone Aceticum 6X, 12X, Aconitum Napellus 12X, Adrenalinum 12X, Dopamine 16X, 30X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0085-1

ANTI-STRESS

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:)

Aids in stimulation of rejuvenating and relaxing mechanisms.†

†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:)

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:)

Aids in stimulation of rejuvenating and relaxing mechanisms.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Apis Mellifica 6X, Citrus Vulgaris 6X, Clematis Vitalba, Flos 6X, Glandula Suprarenalis (Adrenal) 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Kali Phosphoricum 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Scutellaria Lateriflora 6X, Viburnum Opulus 6X, Cortisone Aceticum 6X, 12X, Aconitum Napellus 12X, Adrenalinum 12X, Dopamine 16X, 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0085-1

ANTI-STRESS

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


Raw Label Data

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