Label: SIMPLY HARMONY- ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum tablet
- NDC Code(s): 34666-403-01
- Packager: Nartex Laboratorios Homeopaticos, S.A. De C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 3, 2021
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- Active ingredients
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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.
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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.
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INGREDIENTS AND APPEARANCE
SIMPLY HARMONY
ignatia amara, passiflora incarnata, valeriana officinalis, kali phosphoricum tabletProduct 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)