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

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*


Medication Information

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.

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
  • store in a cool and dry place.
  • do not use if container seal is broken.
Inactive Ingredients

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

Description

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

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.

Active Ingredients

Ignatia amara 3X HPUS*

Passiflora incarnata 3X HPUS*

Valeriana officinalis 3X HPUS*

Kali phosphoricum 6X HPUS*

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.

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.
Inactive Ingredients (Inactive ingredients)

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

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.

Active Ingredients (Active ingredients)

Ignatia amara 3X HPUS*

Passiflora incarnata 3X HPUS*

Valeriana officinalis 3X HPUS*

Kali phosphoricum 6X HPUS*

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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