Synaptol (Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, -

SYNAPTOL (ACONITUM FEROX, ADRENALINUM, AESCULUS HIPPOCASTANUM, FLOS, APIS MELLIFICA, ARGENTUM NITRICUM, AVENA SATIVA, BAPTISIA TINCTORIA, COCHLEARIA ARMORACIA, PHOSPHORUS, SCLERANTHUS ANNUUS,
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NDC	49726-041-60
Set ID	1d5fc1f8-e37c-40b4-b9b3-9b180a8f530a
Category	HUMAN OTC DRUG LABEL
Packager	HelloLife, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE *HPUS INGREDIENTS:

Aconitum Ferox 10X, 30X, 100X, Adrenalinum 10X, 30X, 100X, Aesculus Hippocastanum, Flos 10X, 30X, 100X, Apis Mellifica 10X, 30X, 100X, Argentum Nitricum 10X, 30X, 100X, Avena Sativa 10X, 30X, 100X, Baptisia Tinctoria 10X, 30X, 100X, Cochlearia Armoracia 10X, 30X, 100X, Phosphorus 10X, 30X, 100X, Scleranthus Annuus, Flos 10X, 30X, 100X, Scutellaria Lateriflora 10X, 30X, 100X, Sumbul 10X, 30X, 100X, Viola Odorata 10X, 30X, 100X

Each active ingredient contains equal volumes of 10X, 30X, and 100X potencies.

The letters "HPUS" indicated that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
USES:

For the temporary relief of hyperactivity & inattention symptoms including:

•poor focus

•impulsivity

•difficulty concentrating when reading or writing

Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.
STORAGE & HANDLING:

Do not store next to electrical devices or appliances.

Keep lid tightly closed & store in a cool, dry place.
WARNINGS:

Stop use and as a doctor if symptoms persist or worsen.

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

Keep out of reach of children. Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.

Do not use if tamper seal is broken.
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.
DIRECTIONS:

Dissolve under tongue.

30-50lb (13.6 kg-22.6kg): 1/2 tablet twice daily.

50lb+ (22.6kg): 1 tablet daily.
INDICATIONS:

For the temporary relief of hyperactivity & inattention symptoms including:

•poor focus

•impulsivity

•difficulty concentrating when reading or writing

Product indications based solely on Homeopathic Materia Medica and have not been evaluated by the FDA.
INACTIVE INGREDIENTS:

Advantol 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.
QUESTIONS:

Distributed By:

HelloLife, Inc.

4635 40th St SE

Grand Rapids, MI 49512

www.hellolife.net
PACKAGE LABEL DISPLAY:

NDC 49726-041-60

Synaptol

Natural Hyperactivity &

Inattention Symptom Relief

Homeopathic (OTC) Medicine

60 Quick-dissolving Tablets

INGREDIENTS AND APPEARANCE

SYNAPTOL
aconitum ferox, adrenalinum, aesculus hippocastanum, flos, apis mellifica, argentum nitricum, avena sativa, baptisia tinctoria, cochlearia armoracia, phosphorus, scleranthus annuus, flos, scutellaria lateriflora, sumbul, viola odorata tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49726-041
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM FEROX ROOT (UNII: I4G31A93ZR) (ACONITUM FEROX ROOT - UNII:I4G31A93ZR)	ACONITUM FEROX ROOT	10 [hp_X]
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	10 [hp_X]
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	10 [hp_X]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	10 [hp_X]
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	10 [hp_X]
HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ)	HORSERADISH	10 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]
SCLERANTHUS ANNUUS FLOWERING TOP (UNII: CC4B5WU2XX) (SCLERANTHUS ANNUUS FLOWERING TOP - UNII:CC4B5WU2XX)	SCLERANTHUS ANNUUS FLOWERING TOP	10 [hp_X]
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	10 [hp_X]
FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ)	FERULA SUMBUL ROOT	10 [hp_X]
VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74)	VIOLA ODORATA	10 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
COPOVIDONE (UNII: D9C330MD8B)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	H
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49726-041-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/11/2017

Labeler - HelloLife, Inc. (065619378)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(49726-041) , api manufacture(49726-041) , label(49726-041) , pack(49726-041)

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