Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 0eb82ffc-943e-4fc4-ad03-4f66a70baae5
Route
ORAL
Published
Effective Date 2015-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Ferox Root (100 [hp_X]) Epinephrine Aesculus Hippocastanum Flower Apis Mellifera Silver Cation Avena Sativa Flowering Top Baptisia Tinctoria Root Horseradish Phosphorus Scleranthus Annuus Flowering Top Scutellaria Lateriflora Ferula Sumbul Root Viola Odorata
Inactive Ingredients
Citric Acid Monohydrate Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-08-31

Description

Aconitum ferox HPUS Adrenalinum HPUS Aesculus hippocastanum flos HPUS Apis mellifica HPUS Argentum nitricum HPUS Avena sativa HPUS Baptisia tinctoria HPUS Cochlearia armoracia HPUS Phosphorus HPUS Scleranthus annuus, flos HPUS Scutellaria lateriflora HPUS Sumbul HPUS Viola odorata HPUS Each active ingredient contains equal volumes of 10X, 30X, and 100X 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

Aconitum ferox HPUS........................................Comprehension and understanding confused Adrenalinum HPUS...................................Cannot concentrate Aesculus hippocastanum flos HPUS......................Unable to fix attention Apis mellifica HPUS...........................Cannot concentrate when reading or studying Argentum nitricum HPUS.........................................Very impulsive Avena sativa HPUS.............................................Inability to keep mind on any one subject Baptisia tinctoria HPUS......................................Mentally resless Cochlearia armoracia HPUS................................Difficulty thinking Phosphorus HPUS.......................................................Fidgety Scleranthus annuus, flos HPUS.............................Indecisiveness Scutellaria lateriflora HPUS...................................Inattentiveness Sumbul HPUS..............................................................Easily excited Viola odorata HPUS.......................Disobedience


Medication Information

Purpose

Aconitum ferox HPUS........................................Comprehension and understanding confused

Adrenalinum HPUS...................................Cannot concentrate

Aesculus hippocastanum flos HPUS......................Unable to fix attention

Apis mellifica HPUS...........................Cannot concentrate when reading or studying



Argentum nitricum HPUS.........................................Very impulsive



Avena sativa HPUS.............................................Inability to keep mind on any one subject



Baptisia tinctoria HPUS......................................Mentally resless



Cochlearia armoracia HPUS................................Difficulty thinking



Phosphorus HPUS.......................................................Fidgety



Scleranthus annuus, flos HPUS.............................Indecisiveness



Scutellaria lateriflora HPUS...................................Inattentiveness



Sumbul HPUS..............................................................Easily excited



Viola odorata HPUS.......................Disobedience

Description
  • 30-day supply
  • dropper included
  • Synaptol is made without alcohol or sugar. No gluten added.

Mftd for: HelloLife, Inc.

4460 44th St. SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment #1053442, #3009727070

www.synaptol.com

Uses

For temporary relief of symptoms such as:

  • hyperactivity
  • difficulty reading and writing
  • cannot concentrate when reading or studying

  • inattentivness

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 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 Synaptol directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink.

DOSAGE BY WEIGHT

30-50 LBS (13.6-22.6 kg) -> 1/2 mL twice per day

50+ lbs (22.6+ kg)  -> 1 mL 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

Principal Display Panel



NDC 49726-028-02



SYNAPTOL ®



To temporarily relieve symptoms such as:

  • hyperactivity
  • impulsivity
  • inattentiveness
  • cannot concentrate when reading or studying





2 fl oz (59 mL)

Homeopathic (OTC) Medicine

Active Ingredients (per Dose)

Aconitum ferox HPUS

Adrenalinum HPUS

Aesculus hippocastanum flos HPUS

Apis mellifica HPUS

Argentum nitricum HPUS

Avena sativa HPUS

Baptisia tinctoria HPUS

Cochlearia armoracia HPUS

Phosphorus HPUS

Scleranthus annuus, flos HPUS

Scutellaria lateriflora HPUS

Sumbul HPUS

Viola odorata HPUS

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

For temporary relief of symptoms such as:

  • hyperactivity
  • difficulty reading and writing
  • cannot concentrate when reading or studying

  • inattentivness

Description (34089-3)
  • 30-day supply
  • dropper included
  • Synaptol is made without alcohol or sugar. No gluten added.

Mftd for: HelloLife, Inc.

4460 44th St. SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment #1053442, #3009727070

www.synaptol.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 53414-9 (53414-9)

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

Purpose

Aconitum ferox HPUS........................................Comprehension and understanding confused

Adrenalinum HPUS...................................Cannot concentrate

Aesculus hippocastanum flos HPUS......................Unable to fix attention

Apis mellifica HPUS...........................Cannot concentrate when reading or studying



Argentum nitricum HPUS.........................................Very impulsive



Avena sativa HPUS.............................................Inability to keep mind on any one subject



Baptisia tinctoria HPUS......................................Mentally resless



Cochlearia armoracia HPUS................................Difficulty thinking



Phosphorus HPUS.......................................................Fidgety



Scleranthus annuus, flos HPUS.............................Indecisiveness



Scutellaria lateriflora HPUS...................................Inattentiveness



Sumbul HPUS..............................................................Easily excited



Viola odorata HPUS.......................Disobedience

Warnings

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition

Directions

Dispense Synaptol directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink.

DOSAGE BY WEIGHT

30-50 LBS (13.6-22.6 kg) -> 1/2 mL twice per day

50+ lbs (22.6+ kg)  -> 1 mL 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

Principal Display Panel



NDC 49726-028-02



SYNAPTOL ®



To temporarily relieve symptoms such as:

  • hyperactivity
  • impulsivity
  • inattentiveness
  • cannot concentrate when reading or studying





2 fl oz (59 mL)

Homeopathic (OTC) Medicine

Active Ingredients (per Dose) (Active Ingredients (per dose))

Aconitum ferox HPUS

Adrenalinum HPUS

Aesculus hippocastanum flos HPUS

Apis mellifica HPUS

Argentum nitricum HPUS

Avena sativa HPUS

Baptisia tinctoria HPUS

Cochlearia armoracia HPUS

Phosphorus HPUS

Scleranthus annuus, flos HPUS

Scutellaria lateriflora HPUS

Sumbul HPUS

Viola odorata HPUS

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

All Sections (JSON)