Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 96e0dc92-c4b4-4e8a-9bc8-d8a697f9ad4c
Route
ORAL
Published
Effective Date 2023-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clematis Vitalba Flower (6 [hp_X]) Convallaria Majalis (12 [hp_X]) Helianthemum Nummularium Flower (30 [hp_X]) Impatiens Glandulifera Flower Ornithogalum Umbellatum Flowering Top Prunus Cerasifera Flower Sus Scrofa Cerebellum Atropa Belladonna Phosphorus Sepia Officinalis Juice Beef Kidney Lycopodium Clavatum Spore
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-24

Description

Clematis Vitalba, Flos 6X, Convallaria Majalis 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Cerebellum 6X, 12X, Belladonna 12X, Phosphorus 12X, Sepia 12X, Kidney 30X, Lycopodium Clavatum 30X.

Purpose

Aids in temporary increasing mental clarity.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary increasing mental clarity.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Clematis Vitalba, Flos 6X, Convallaria Majalis 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Cerebellum 6X, 12X, Belladonna 12X, Phosphorus 12X, Sepia 12X, Kidney 30X, Lycopodium Clavatum 30X.

Purpose:

Aids in temporary increasing mental clarity.†

†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 temporary increasing mental clarity.†

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

Active Ingredients:

Clematis Vitalba, Flos 6X, Convallaria Majalis 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Cerebellum 6X, 12X, Belladonna 12X, Phosphorus 12X, Sepia 12X, Kidney 30X, Lycopodium Clavatum 30X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0083-1

ATTENTION

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 temporary increasing mental clarity.†

†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 temporary increasing mental clarity.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Clematis Vitalba, Flos 6X, Convallaria Majalis 6X, Helianthemum Nummularium, Flos 6X, Impatiens Glandulifera, Flos 6X, Ornithogalum Umbellatum, Flos 6X, Prunus Cerasifera, Flos 6X, Cerebellum 6X, 12X, Belladonna 12X, Phosphorus 12X, Sepia 12X, Kidney 30X, Lycopodium Clavatum 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0083-1

ATTENTION

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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