Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID ccaf3166-5e2f-4c7f-80a8-ee722bdf0c5b
Route
ORAL
Published
Effective Date 2024-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Valerian (2 [hp_X]) Centella Asiatica (3 [hp_X]) Melatonin (6 [hp_X]) Sus Scrofa Cerebrum (9 [hp_X]) Sus Scrofa Hypothalamus (12 [hp_X]) Sus Scrofa Pineal Gland (15 [hp_X]) Scutellaria Lateriflora Whole Stellaria Media Oyster Shell Calcium Carbonate, Crude Zinc Gold Dopamine Serotonin Magnesium Cation
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-07-24

Description

Valeriana Officinalis 2X, Hydrocotyle Asiatica 3X, Melatonin 3X, Cerebrum Suis 6X, Hypothalamus Suis 6X, Pineal Gland (Suis) 6X, Scutellaria Lateriflora 6X, Stellaria Media 6X, Calcarea Carbonica 9X, Zincum Metallicum 9X, Aurum Metallicum 12X, Dopamine (Hydrochloride) 12X, 16X, Serotonin (Hydrochloride) 12X, 16X, Magnesia Muriatica 15X.

Purpose

Provides potentized homeo-nutritional support of the pineal.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Provides potentized homeo-nutritional support of the pineal.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Valeriana Officinalis 2X, Hydrocotyle Asiatica 3X, Melatonin 3X, Cerebrum Suis 6X, Hypothalamus Suis 6X, Pineal Gland (Suis) 6X, Scutellaria Lateriflora 6X, Stellaria Media 6X, Calcarea Carbonica 9X, Zincum Metallicum 9X, Aurum Metallicum 12X, Dopamine (Hydrochloride) 12X, 16X, Serotonin (Hydrochloride) 12X, 16X, Magnesia Muriatica 15X.

Purpose:

Provides potentized homeo-nutritional support of the pineal.†

†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 1 to 2 teaspoons one to two times daily. Children under twelve one half adult dosage. Consult a physician for use in children under 12 years of age.

Indications:

Provides potentized homeo-nutritional support of the pineal.†

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

Active Ingredients:

Valeriana Officinalis 2X, Hydrocotyle Asiatica 3X, Melatonin 3X, Cerebrum Suis 6X, Hypothalamus Suis 6X, Pineal Gland (Suis) 6X, Scutellaria Lateriflora 6X, Stellaria Media 6X, Calcarea Carbonica 9X, Zincum Metallicum 9X, Aurum Metallicum 12X, Dopamine (Hydrochloride) 12X, 16X, Serotonin (Hydrochloride) 12X, 16X, Magnesia Muriatica 15X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0142-1

PINEAL

LIQUESCENCE

4 FL. OZ (120 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:)

Provides potentized homeo-nutritional support of the pineal.†

†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 1 to 2 teaspoons one to two times daily. Children under twelve one half adult dosage. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

Provides potentized homeo-nutritional support of the pineal.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Valeriana Officinalis 2X, Hydrocotyle Asiatica 3X, Melatonin 3X, Cerebrum Suis 6X, Hypothalamus Suis 6X, Pineal Gland (Suis) 6X, Scutellaria Lateriflora 6X, Stellaria Media 6X, Calcarea Carbonica 9X, Zincum Metallicum 9X, Aurum Metallicum 12X, Dopamine (Hydrochloride) 12X, 16X, Serotonin (Hydrochloride) 12X, 16X, Magnesia Muriatica 15X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0142-1

PINEAL

LIQUESCENCE

4 FL. OZ (120 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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