SPL v2
SPL
SPL Set ID e881ae75-ba7b-3eab-e053-2995a90af844
Route
ORAL
Published
Effective Date 2022-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Populus Tremula Flowering Top (5 [hp_X]) Magnesium Cation (12 [hp_X]) Juglans Regia Flowering Top (6 [hp_X]) Oyster Shell Calcium Carbonate, Crude Ulmus Procera Flowering Twig Potassium Phosphate, Unspecified Form Phosphate Ion Mimulus Guttatus Flowering Top Ornithogalum Umbellatum Flowering Top
Inactive Ingredients
Potato Water Matricaria Recutita Flowering Top

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-13

Description

Each dose contains equal parts of: Aspen 5X HPUS Calc Carb 12X HPUS Calc Phos 12X HPUS Elm 5X HPUS Kali Phos 6X HPUS Mag Phos 12X HPUS Mimulus 5X HPUS Star of Bethlehem 5X HPUS Walnut 5X HPUS


Medication Information

Indications and Usage

temporarily relieves symptoms of

• well defined fears

• vague unknown fears

• protection from outside influences

• nervous dread • overwhelmed

indications are based on homeopathic materia medica, not clinical tests.

Dosage and Administration

• best if used in the morning and just before bed

• use 5 days per week until symptoms are relieved

adults and children 12 years and over 4-5 sprays in mouth twice per day

children 2 years to under 12 years 2-3 sprays in mouth twice per day

children under 2 years consult a doctor

Description

Questions or Comments?

Call 800.570.0021 Between 9am-5pm PST [email protected] siddharemedies.com MFD by Siddha Remedies

Oxnard, CA 93030

Made in USA

Section 43685-7

Warnings

Stop use and ask a doctor if symptoms persist or worsen

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

Keep out of reach of children

Section 44425-7

• do not use if plastic seal around cap is broken or missing.

• store in a cool, dry place.

Section 50565-1

Keep out of reach of children

Section 51727-6

Chamomile*, Distilled Water, Natural Flavor, Potato*

Section 51945-4

non GMO • no alcohol

NDC: 69779-029-01

fear less

Well Defined Fears Vague Unknown Fears Fear of Being ill

sugar, dairy & gluten free

Homeopathic Remedy

1 US fl oz (29.6mL)

Section 53414-9

If pregnant or breast-feeding ask a

health professional before use

Section 55105-1

Each dose contains equal parts of:



Aspen 5X HPUS ............vague unknown fears

Calc Carb 12X HPUS ........ full of fears, fear of being ill or unfortunate

Calc Phos 12X HPUS .......... depressed spirits, peevish and fretful

Elm 5X HPUS........... overwhelmed with things

Kali Phos 6X HPUS ....nervous dread; looks on the dark side of everything

Mag Phos 12X HPUS .... persistent depression of spirits

Mimulus 5X HPUS.....your anxieties cause you inner tension, well defined fears

Star of Bethlehem 5X HPUS..... after-effects of physical, mental, or emotional shock that occurred recently or long ago

Walnut 5X HPUS......constancy and protection from outside influences

The letters HPUS indicate that these ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 55106-9

Each dose contains equal parts of:



Aspen 5X HPUS

Calc Carb 12X HPUS

Calc Phos 12X HPUS

Elm 5X HPUS

Kali Phos 6X HPUS

Mag Phos 12X HPUS

Mimulus 5X HPUS

Star of Bethlehem 5X HPUS

Walnut 5X HPUS

Side Panel

homeopathy &

flower essences:

• Jump start your body’s

natural ability to heal

• Natural, safe and

non-habit forming

• No contraindications.

May be effectively

used with drugs and

other supplements

• Alcohol, sugar, dairy &

gluten free

• Prepared in distilled

water with natural

preservatives

• Blends time-tested

natural medicine with

modern technology

• One month supply

Full Warning Panel

Warnings

Stop use and ask a doctor if symptoms

persist or worsen

If pregnant or breast-feeding ask a

health professional before use

Keep out of reach of children


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves symptoms of

• well defined fears

• vague unknown fears

• protection from outside influences

• nervous dread • overwhelmed

indications are based on homeopathic materia medica, not clinical tests.

Dosage and Administration (34068-7)

• best if used in the morning and just before bed

• use 5 days per week until symptoms are relieved

adults and children 12 years and over 4-5 sprays in mouth twice per day

children 2 years to under 12 years 2-3 sprays in mouth twice per day

children under 2 years consult a doctor

Description (34089-3)

Questions or Comments?

Call 800.570.0021 Between 9am-5pm PST [email protected] siddharemedies.com MFD by Siddha Remedies

Oxnard, CA 93030

Made in USA

Section 43685-7 (43685-7)

Warnings

Stop use and ask a doctor if symptoms persist or worsen

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

Keep out of reach of children

Section 44425-7 (44425-7)

• do not use if plastic seal around cap is broken or missing.

• store in a cool, dry place.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Chamomile*, Distilled Water, Natural Flavor, Potato*

Section 51945-4 (51945-4)

non GMO • no alcohol

NDC: 69779-029-01

fear less

Well Defined Fears Vague Unknown Fears Fear of Being ill

sugar, dairy & gluten free

Homeopathic Remedy

1 US fl oz (29.6mL)

Section 53414-9 (53414-9)

If pregnant or breast-feeding ask a

health professional before use

Section 55105-1 (55105-1)

Each dose contains equal parts of:



Aspen 5X HPUS ............vague unknown fears

Calc Carb 12X HPUS ........ full of fears, fear of being ill or unfortunate

Calc Phos 12X HPUS .......... depressed spirits, peevish and fretful

Elm 5X HPUS........... overwhelmed with things

Kali Phos 6X HPUS ....nervous dread; looks on the dark side of everything

Mag Phos 12X HPUS .... persistent depression of spirits

Mimulus 5X HPUS.....your anxieties cause you inner tension, well defined fears

Star of Bethlehem 5X HPUS..... after-effects of physical, mental, or emotional shock that occurred recently or long ago

Walnut 5X HPUS......constancy and protection from outside influences

The letters HPUS indicate that these ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 55106-9 (55106-9)

Each dose contains equal parts of:



Aspen 5X HPUS

Calc Carb 12X HPUS

Calc Phos 12X HPUS

Elm 5X HPUS

Kali Phos 6X HPUS

Mag Phos 12X HPUS

Mimulus 5X HPUS

Star of Bethlehem 5X HPUS

Walnut 5X HPUS

Side Panel

homeopathy &

flower essences:

• Jump start your body’s

natural ability to heal

• Natural, safe and

non-habit forming

• No contraindications.

May be effectively

used with drugs and

other supplements

• Alcohol, sugar, dairy &

gluten free

• Prepared in distilled

water with natural

preservatives

• Blends time-tested

natural medicine with

modern technology

• One month supply

Full Warning Panel

Warnings

Stop use and ask a doctor if symptoms

persist or worsen

If pregnant or breast-feeding ask a

health professional before use

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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