SIMPLY HARMONY- ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum tablet

Simply Harmony by

Drug Labeling and Warnings

Simply Harmony by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos, S.A. De C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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.

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.

Warnings

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.

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.

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

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

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

Questions or comments?

informacion@nartexlabs.com 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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SIMPLY HARMONY 
ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-403
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	DIBASIC POTASSIUM PHOSPHATE	6 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	LogoNartex
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-403-01	1 in 1 CARTON	12/03/2021
1		120 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/03/2021

Labeler - Nartex Laboratorios Homeopaticos, S.A. De C.V. (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos, S.A. De C.V.		589914576	manufacture(34666-403)