Synaptol Lactose Free by HelloLife, Inc. / Apotheca Company DRUG FACTS:

Synaptol Lactose Free by

Drug Labeling and Warnings

Synaptol Lactose Free by is a Homeopathic medication manufactured, distributed, or labeled by HelloLife, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SYNAPTOL LACTOSE FREE- 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 
HelloLife, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

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

fidgeting

difficulty concentrating when reading or writing

Product indications are 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 ifsymptoms persist or worsen.

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

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control center right away.

Do not use if tamper seal is broken.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

30 sec. under tongue, then swallow with water.

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

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

INDICATIONS:

for the temporary relief of hyperactivity & inattention symptoms including:

poor focus

impulsivity

fidgeting

difficulty concentrating when reading or writing

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

INACTIVE INGREDIENTS:

Magnesium Stearate, Microcrystalline Cellulose, Sucrose

QUESTIONS:

Distributed By:

HelloLife, Inc.

4655 Patterson Ave SE, Ste. C

Grand Rapids, MI 49512

www.hellolife.net

PACKAGE LABEL DISPLAY:

Synaptol Lactose Free

NDC: 49726-048-60

Synaptol Lactose Free Tablets

Natural Hyperactivity &

Inattention Symptom Relief

Homeopathic (OTC) Medicine

60 Dissolving Tablets

SYNAPTOL LACTOSE FREE 
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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 49726-048
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM FEROX ROOT (UNII: I4G31A93ZR) (ACONITUM FEROX ROOT - UNII:I4G31A93ZR) ACONITUM FEROX ROOT10 [hp_X]
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE10 [hp_X]
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [hp_X]
HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH10 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]
SCLERANTHUS ANNUUS FLOWERING TOP (UNII: CC4B5WU2XX) (SCLERANTHUS ANNUUS FLOWERING TOP - UNII:CC4B5WU2XX) SCLERANTHUS ANNUUS FLOWERING TOP10 [hp_X]
SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA WHOLE - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA WHOLE10 [hp_X]
FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT10 [hp_X]
VIOLA ODORATA WHOLE (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA WHOLE10 [hp_X]
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49726-048-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/27/202207/01/2024
Labeler - HelloLife, Inc. (065619378)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(49726-048) , api manufacture(49726-048) , label(49726-048) , pack(49726-048)

Revised: 12/2024
 

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