Simply Harmony

Simply Harmony
SPL v1
SPL
SPL Set ID d244bc14-51d2-2c4c-e053-2995a90a63a9
Route
ORAL
Published
Effective Date 2021-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Passiflora Incarnata Flowering Top (3 [hp_X]) Valerian (6 [hp_X]) Phosphate Ion Strychnos Ignatii Seed
Inactive Ingredients
Lactose, Unspecified Form Starch, Potato Talc Water Sodium Benzoate Gelatin Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: LogoNartex Shape: round Color: white Size: 9 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-12-03

Description

Ignatia amara 3X HPUS* Passiflora incarnata 3X HPUS* Valeriana officinalis 3X HPUS* Kali phosphoricum 6X HPUS*

Purpose

Ignatia amara 3X HPUS*.................................Headache, mental fatigue and insomnia from emotional disorders Passiflora incarnata 3X HPUS*........................Sleeplessness from worries and restlessness Valeriana officinalis 3X HPUS*........................Restless sleep Kali phosphoricum 6X HPUS*.........................Mental fatigue, difficulty concentrating, headaches, occasional sleeplessness *The letters "HPUS" indicate that the compoennts in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.


Medication Information

Purpose

Ignatia amara 3X HPUS*.................................Headache, mental fatigue and insomnia from emotional disorders

Passiflora incarnata 3X HPUS*........................Sleeplessness from worries and restlessness

Valeriana officinalis 3X HPUS*........................Restless sleep

Kali phosphoricum 6X HPUS*.........................Mental fatigue, difficulty concentrating, headaches, occasional sleeplessness

*The letters "HPUS" indicate that the compoennts in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Description

Ignatia amara 3X HPUS* Passiflora incarnata 3X HPUS* Valeriana officinalis 3X HPUS* Kali phosphoricum 6X HPUS*

Uses

For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • conditoin worsens.
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
  • rash develops.
Section 50570-1

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product.
Section 51945-4

NDC 34666-403-01

SIMPLY Harmony

Mental Fatigue Relief

  • Stay Calm
  • Stay Sharp
  • Stay Focused
  • Mood Support

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

120 Tablets

Section 53414-9

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

Directions
  • adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth.
  • children under 12 years, consult a physician.
Other Information
  • store in a cool and dry place.
  • do not use if container seal is broken.
Active Ingredients

Ignatia amara 3X HPUS*

Passiflora incarnata 3X HPUS*

Valeriana officinalis 3X HPUS*

Kali phosphoricum 6X HPUS*

Inactive Ingredients

Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP

Questions Or Comments?

[email protected] or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.


Structured Label Content

Uses

For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • conditoin worsens.
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
  • rash develops.
Section 50570-1 (50570-1)

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product.
Section 51945-4 (51945-4)

NDC 34666-403-01

SIMPLY Harmony

Mental Fatigue Relief

  • Stay Calm
  • Stay Sharp
  • Stay Focused
  • Mood Support

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

120 Tablets

Section 53414-9 (53414-9)

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

Purpose

Ignatia amara 3X HPUS*.................................Headache, mental fatigue and insomnia from emotional disorders

Passiflora incarnata 3X HPUS*........................Sleeplessness from worries and restlessness

Valeriana officinalis 3X HPUS*........................Restless sleep

Kali phosphoricum 6X HPUS*.........................Mental fatigue, difficulty concentrating, headaches, occasional sleeplessness

*The letters "HPUS" indicate that the compoennts in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Directions
  • adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth.
  • children under 12 years, consult a physician.
Other Information (Other information)
  • store in a cool and dry place.
  • do not use if container seal is broken.
Active Ingredients (Active ingredients)

Ignatia amara 3X HPUS*

Passiflora incarnata 3X HPUS*

Valeriana officinalis 3X HPUS*

Kali phosphoricum 6X HPUS*

Inactive Ingredients (Inactive ingredients)

Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP

Questions Or Comments? (Questions or comments?)

[email protected] or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.


Advanced Ingredient Data


Raw Label Data

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