SPL v8
SPL
SPL Set ID 5493cd3d-a021-4832-8941-27d2d7b625eb
Route
ORAL
Published
Effective Date 2016-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Semecarpus Anacardium Juice (10 [hp_X]) Larix Decidua Flowering Top Gold Avena Sativa Flowering Top Oyster Shell Calcium Carbonate, Crude Cinchona Officinalis Bark Hypericum Perforatum Bromide Ion Sodium Sulfate Anhydrous Tobacco Leaf Strychnos Ignatii Seed Pulsatilla Vulgaris Sepia Officinalis Juice Sinapis Arvensis Flowering/fruiting Top Carbonate Ion Phosphoric Acid Phosphorus Carpinus Betulus Flowering Top Black Cohosh
Inactive Ingredients
Anhydrous Citric Acid Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-03-08

Description

Anacardium orientale, Larix decidua, flos HPUS Aurum metallicum HPUS Avena sativa HPUS Calcarea carbonica HPUS Carpinus betulus, flos, Phosphorus, HPUS Cimicifuga racemosa, Natrum carbonicum HPUS Cinchona officinalis HPUS Hypericum perforatum, Kali bromatum, Natrum sulphuricum, Tabacum HPUS Ignatia amara, Pulsatilla, Sepia, Sinapis arvensis, flos HPUS Phosphoricum acidum HPUS Each active ingredient contains equal volumes of 10X, 30X and LM1 potencies. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.

Purpose

Anacardium orientale, Larix decidua, flos HPUS.............................................................................................Lack of self-confidence Aurum metallicum HPUS..................................................................................................................................Worthlessness Avena sativa HPUS........................................................................................................................................ Nervous exhaustion Calcarea carbonica HPUS..............................................................................................................................Apprehension Carpinus betulus, flos, Phosphorus, HPUS....................................................................................................Indifference Cimicifuga racemosa, Natrum carbonicum HPUS............................................................................................Worry Cinchona officinalis HPUS...............................................................................................................................Discouragement Hypericum perforatum, Kali bromatum, Natrum sulphuricum, Tabacum HPUS...............................................Melancholy Ignatia amara, Pulsatilla, Sepia, Sinapis arvensis, flos HPUS.........................................................................Sadness Phosphoricum acidum HPUS...........................................................................................................................Grief


Medication Information

Purpose
Anacardium orientale, Larix decidua, flos HPUS.............................................................................................Lack of self-confidence
Aurum metallicum HPUS..................................................................................................................................Worthlessness
Avena sativa HPUS........................................................................................................................................ Nervous exhaustion
Calcarea carbonica HPUS..............................................................................................................................Apprehension
Carpinus betulus, flos, Phosphorus, HPUS....................................................................................................Indifference

Cimicifuga racemosa, Natrum carbonicum HPUS............................................................................................Worry

Cinchona officinalis HPUS...............................................................................................................................Discouragement
Hypericum perforatum, Kali bromatum, Natrum sulphuricum, Tabacum HPUS...............................................Melancholy
Ignatia amara, Pulsatilla, Sepia, Sinapis arvensis, flos HPUS.........................................................................Sadness
Phosphoricum acidum HPUS...........................................................................................................................Grief








Description
•    30-day supply

•    dropper included

•    MoodBrite is made without alcohol or sugar. No gluten added.




Mftd for:  HelloLife, LLC.

4460 44th St SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.moodbrite.com

Uses

to temporarily relieve symptoms commonly associated with seasonal depression such as:

  • melancholy
  • sadness
  • worthlessness
  • discouragement






Section 50565-1

Keep out of the reach of children.

Section 50566-9
Stop use and ask a doctor if symptoms persist or worsen.



Section 50567-7

When using this product use only as directed.

Section 51945-4

NDC 49726-031-02 

MOODBRITE TM



Seasonal Depression Symptom Relief



To temporarily relieve symptoms commonly associated with seasonal depression such as:



•    melancholy

•    sadness

•    worthlessness

•    discouragement  

2 fl oz (59 mL)

Homeopathic (OTC) Medicine

Section 53414-9

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

Warnings




Ask a doctor before use if


•    you are taking any other medications

•    you have a medical condition



Directions

Dispense MoodBrite directly into mouth, or add recommended dosage into 8-12 oz. purified (non-chlorinated) water and drink. Safe for ages 2 and up.



DOSAGE BY WEIGHT



30-50 lbs                   1/2 mL

(13.6-22.6 kg)           twice per day



50+ lbs                      1 mL

(22.6+ kg)                  twice per day



Other Information
  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal
  • do not store next to electrical devices or appliances
Inactive Ingredients
citric acid, potassium sorbate, purified ionized mineral water


Questions Or Comments?

You can email us at [email protected] or call us toll-free at 1.800.875.0850



Monday through Friday 9am-5pm ET



Active Ingredients (per Dose)
Anacardium orientale, Larix decidua, flos HPUS


Aurum metallicum HPUS


Avena sativa HPUS


Calcarea carbonica HPUS


Carpinus betulus, flos, Phosphorus, HPUS


Cimicifuga racemosa, Natrum carbonicum HPUS



Cinchona officinalis HPUS


Hypericum perforatum, Kali bromatum, Natrum sulphuricum, Tabacum HPUS


Ignatia amara, Pulsatilla, Sepia, Sinapis arvensis, flos HPUS





Phosphoricum acidum HPUS



Each active ingredient contains equal volumes of 10X, 30X and LM1 potencies. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.






Structured Label Content

Uses

to temporarily relieve symptoms commonly associated with seasonal depression such as:

  • melancholy
  • sadness
  • worthlessness
  • discouragement






Description (34089-3)
•    30-day supply

•    dropper included

•    MoodBrite is made without alcohol or sugar. No gluten added.




Mftd for:  HelloLife, LLC.

4460 44th St SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.moodbrite.com

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)
Stop use and ask a doctor if symptoms persist or worsen.



Section 50567-7 (50567-7)

When using this product use only as directed.

Section 51945-4 (51945-4)

NDC 49726-031-02 

MOODBRITE TM



Seasonal Depression Symptom Relief



To temporarily relieve symptoms commonly associated with seasonal depression such as:



•    melancholy

•    sadness

•    worthlessness

•    discouragement  

2 fl oz (59 mL)

Homeopathic (OTC) Medicine

Section 53414-9 (53414-9)

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

Purpose
Anacardium orientale, Larix decidua, flos HPUS.............................................................................................Lack of self-confidence
Aurum metallicum HPUS..................................................................................................................................Worthlessness
Avena sativa HPUS........................................................................................................................................ Nervous exhaustion
Calcarea carbonica HPUS..............................................................................................................................Apprehension
Carpinus betulus, flos, Phosphorus, HPUS....................................................................................................Indifference

Cimicifuga racemosa, Natrum carbonicum HPUS............................................................................................Worry

Cinchona officinalis HPUS...............................................................................................................................Discouragement
Hypericum perforatum, Kali bromatum, Natrum sulphuricum, Tabacum HPUS...............................................Melancholy
Ignatia amara, Pulsatilla, Sepia, Sinapis arvensis, flos HPUS.........................................................................Sadness
Phosphoricum acidum HPUS...........................................................................................................................Grief








Warnings




Ask a doctor before use if


•    you are taking any other medications

•    you have a medical condition



Directions

Dispense MoodBrite directly into mouth, or add recommended dosage into 8-12 oz. purified (non-chlorinated) water and drink. Safe for ages 2 and up.



DOSAGE BY WEIGHT



30-50 lbs                   1/2 mL

(13.6-22.6 kg)           twice per day



50+ lbs                      1 mL

(22.6+ kg)                  twice per day



Other Information (Other information)
  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal
  • do not store next to electrical devices or appliances
Inactive Ingredients (Inactive ingredients)
citric acid, potassium sorbate, purified ionized mineral water


Questions Or Comments? (Questions or comments?)

You can email us at [email protected] or call us toll-free at 1.800.875.0850



Monday through Friday 9am-5pm ET



Active Ingredients (per Dose) (Active Ingredients (per dose))
Anacardium orientale, Larix decidua, flos HPUS


Aurum metallicum HPUS


Avena sativa HPUS


Calcarea carbonica HPUS


Carpinus betulus, flos, Phosphorus, HPUS


Cimicifuga racemosa, Natrum carbonicum HPUS



Cinchona officinalis HPUS


Hypericum perforatum, Kali bromatum, Natrum sulphuricum, Tabacum HPUS


Ignatia amara, Pulsatilla, Sepia, Sinapis arvensis, flos HPUS





Phosphoricum acidum HPUS



Each active ingredient contains equal volumes of 10X, 30X and LM1 potencies. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.






Advanced Ingredient Data


Raw Label Data

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