Label: SERENE SLEEP (eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla- pratensis, ignatia amara, kali phosphoricum, rhus tox spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50181-0080-1 - Packager: The Wellness Center for Research a
- 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 February 14, 2022
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN SECTION
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
SERENE SLEEP
eschscholtzia californica, chamomilla, cina, coffea cruda, nux vomica, passiflora incarnata, pulsatilla (pratensis), ignatia amara, kali phosphoricum, rhus tox sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESCHSCHOLZIA CALIFORNICA WHOLE (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X) ESCHSCHOLZIA CALIFORNICA WHOLE 3 [hp_C] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 3 [hp_C] in 1 mL ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 6 [hp_C] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_C] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_C] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_C] in 1 mL PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 6 [hp_C] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_C] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 30 [hp_C] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50181-0080-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/14/2022 Labeler - The Wellness Center for Research a (832363993) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50181-0080) , api manufacture(50181-0080) , label(50181-0080) , pack(50181-0080)