Drug Facts

Drug Facts
SPL v16
SPL
SPL Set ID 7e101452-b7e0-4676-b4b5-6a83a246e829
Route
ORAL
Published
Effective Date 2015-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Alfalfa Silver Cation Gold Avena Sativa Flowering Top Barium Cation Calcium Cation Chamomile Gelsemium Sempervirens Root Nitroglycerin Strychnos Ignatii Seed Arsenite Ion Phosphate Ion Hops Hydrochloric Acid Passiflora Incarnata Flower Phosphorus Delphinium Staphisagria Seed Datura Stramonium Arsenic Cation (3+)
Inactive Ingredients
Water Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-04-01

Description

Aconitum napellus HPUS, Alfalfa HPUS, Argentum nitricum HPUS, Arsenicum Album HPUS, Aurum metallicum HPUS, Avena sativa HPUS, Baryta carbonica HPUS, Calcarea phosphorica HPUS, Chamomilla HPUS, Gelsemium semperivirens HPUS, Glonoinum HPUS, Ignatia amara HPUS, Kali arsenicosum HPUS, Kali phosphoricum HPUS, Lupulus humulus HPUS, Muriaticum acidum HPUS, Natrum phosphoricum HPUS, Passiflora incarnata HPUS, Phosphorus HPUS, Staphysagria HPUS, Stramonium HPUS.  Each active ingredient contains equal volumes of 10x, 30x, 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

Aconitum napellus HPUS............................Emotional Tension Alfala HPUS..............................................Gloominess Argentum nitricum HPUS............................Tremulousness Arsenicum album HPUS.............................Anguish Aurum metallicum HPUS............................Hopelessness Avena Sativa HPUS...................................Nervous Exhaustion Baryta carbonica HPUS..............................Loss of self-confidence Calcarea phosphorica HPUS.......................Forgetfullness Chamomilla HPUS.....................................Impatience Gelsemium sempervirens HPUS.................Emotional Excitement Glonoinum HPUS.......................................Extreme irritability Humulus lupulus HPUS...............................Nervous tremors Ignatia amara HPUS....................................Hysteria Kali arsenicosum HPUS..............................Nervousness Kali phosphoricum HPUS............................Fretfulness Natrum phosphoricum HPUS.......................Fear Passiflora incarnata HPUS..........................Abnormal sleep Phosphorus HPUS.....................................Low spirits Staphysagria HPUS...................................Emotional sensitivity Stramonium HPUS....................................Mood Swings


Medication Information

Purpose

Aconitum napellus HPUS............................Emotional Tension

Alfala HPUS..............................................Gloominess

Argentum nitricum HPUS............................Tremulousness

Arsenicum album HPUS.............................Anguish

Aurum metallicum HPUS............................Hopelessness

Avena Sativa HPUS...................................Nervous Exhaustion

Baryta carbonica HPUS..............................Loss of self-confidence

Calcarea phosphorica HPUS.......................Forgetfullness

Chamomilla HPUS.....................................Impatience

Gelsemium sempervirens HPUS.................Emotional Excitement

Glonoinum HPUS.......................................Extreme irritability

Humulus lupulus HPUS...............................Nervous tremors

Ignatia amara HPUS....................................Hysteria

Kali arsenicosum HPUS..............................Nervousness

Kali phosphoricum HPUS............................Fretfulness

Natrum phosphoricum HPUS.......................Fear

Passiflora incarnata HPUS..........................Abnormal sleep

Phosphorus HPUS.....................................Low spirits

Staphysagria HPUS...................................Emotional sensitivity

Stramonium HPUS....................................Mood Swings

Description

  • 30-day supply
  • dropper included
  • Anxietin 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.anxietin.com





Uses

For the temporary relief of anxiety symptoms including:

  • fear
  • nervousness
  • sensitivity
  • minor mood swings
  • upset and tightness in stomach and body
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, take only on the advice of a physician.

Warnings

Ask a doctor before use if

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

Directions

Dispense Anxietin directly into mouth, or add recommended dosage into 8-12 oz. of 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

Principal Display Panel

NDC 49726-018-02

ANXIETIN TM

Anxiety Symptom Relief

For temporary relief of anxiety symptoms including:

  • fear
  • nervousness
  • sensitivity
  • minor mood swings
  • upset and tightness in stomach and body
2 FL OZ (59 mL)

Homeopathic (OTC) Medicine

Active Ingredients (per Dose)

Aconitum napellus HPUS, Alfalfa HPUS, Argentum nitricum HPUS, Arsenicum Album HPUS, Aurum metallicum HPUS, Avena sativa HPUS, Baryta carbonica HPUS, Calcarea phosphorica HPUS, Chamomilla HPUS, Gelsemium semperivirens HPUS, Glonoinum HPUS, Ignatia amara HPUS, Kali arsenicosum HPUS, Kali phosphoricum HPUS, Lupulus humulus HPUS, Muriaticum acidum HPUS, Natrum phosphoricum HPUS, Passiflora incarnata HPUS, Phosphorus HPUS, Staphysagria HPUS, Stramonium HPUS.  Each active ingredient contains equal volumes of 10x, 30x, 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

For the temporary relief of anxiety symptoms including:

  • fear
  • nervousness
  • sensitivity
  • minor mood swings
  • upset and tightness in stomach and body
Description (34089-3)

  • 30-day supply
  • dropper included
  • Anxietin 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.anxietin.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, take only on the advice of a physician.

Purpose

Aconitum napellus HPUS............................Emotional Tension

Alfala HPUS..............................................Gloominess

Argentum nitricum HPUS............................Tremulousness

Arsenicum album HPUS.............................Anguish

Aurum metallicum HPUS............................Hopelessness

Avena Sativa HPUS...................................Nervous Exhaustion

Baryta carbonica HPUS..............................Loss of self-confidence

Calcarea phosphorica HPUS.......................Forgetfullness

Chamomilla HPUS.....................................Impatience

Gelsemium sempervirens HPUS.................Emotional Excitement

Glonoinum HPUS.......................................Extreme irritability

Humulus lupulus HPUS...............................Nervous tremors

Ignatia amara HPUS....................................Hysteria

Kali arsenicosum HPUS..............................Nervousness

Kali phosphoricum HPUS............................Fretfulness

Natrum phosphoricum HPUS.......................Fear

Passiflora incarnata HPUS..........................Abnormal sleep

Phosphorus HPUS.....................................Low spirits

Staphysagria HPUS...................................Emotional sensitivity

Stramonium HPUS....................................Mood Swings

Warnings

Ask a doctor before use if

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

Directions

Dispense Anxietin directly into mouth, or add recommended dosage into 8-12 oz. of 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 (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 49726-018-02

ANXIETIN TM

Anxiety Symptom Relief

For temporary relief of anxiety symptoms including:

  • fear
  • nervousness
  • sensitivity
  • minor mood swings
  • upset and tightness in stomach and body
2 FL OZ (59 mL)

Homeopathic (OTC) Medicine

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

Aconitum napellus HPUS, Alfalfa HPUS, Argentum nitricum HPUS, Arsenicum Album HPUS, Aurum metallicum HPUS, Avena sativa HPUS, Baryta carbonica HPUS, Calcarea phosphorica HPUS, Chamomilla HPUS, Gelsemium semperivirens HPUS, Glonoinum HPUS, Ignatia amara HPUS, Kali arsenicosum HPUS, Kali phosphoricum HPUS, Lupulus humulus HPUS, Muriaticum acidum HPUS, Natrum phosphoricum HPUS, Passiflora incarnata HPUS, Phosphorus HPUS, Staphysagria HPUS, Stramonium HPUS.  Each active ingredient contains equal volumes of 10x, 30x, 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.




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