Label: OHM SLEEP WELL- avena sativa, coffea cruda, ignatia amara, nux vomica, passiflora, incarnata, stramonium, valeriana officinalis. liquid
- NDC Code(s): 66096-727-05
- Packager: OHM PHARMA INC.
- Category: HUMAN OTC DRUG LABEL
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 29, 2021
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Avena Sativa 4X, Coffea Cruda 30C, Ignatia Amara 12C, Nux Vomica 30C, Passiflora Incarnata 4X, Stramonium 30C, Valeriana Officinalis 4X.
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
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INGREDIENTS AND APPEARANCE
OHM SLEEP WELL
avena sativa, coffea cruda, ignatia amara, nux vomica, passiflora, incarnata, stramonium, valeriana officinalis. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66096-727 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 4 [hp_X] in 59 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 30 [hp_C] in 59 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 12 [hp_C] in 59 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 59 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X] in 59 mL DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 30 [hp_C] in 59 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 4 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66096-727-05 59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/21/2017 Labeler - OHM PHARMA INC. (030572478)
