Label: SLEEPOLOGY- alfalfa, avena sativa, chamomilla, eschscholtzia californica, gelsemium sempervirens, nux moschata, passiflora incarnata, piper methysticum, valeriana officinalis tablet, chewable
- NDC Code(s): 69676-0012-1, 69676-0012-3
- Packager: Genexa 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 July 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
ACTIVE INGREDIENT
Active ingredients ‡**
Alfalfa 6X HPUS
Avena sativa 6X HPUS
Chamomilla 6X HPUS
Eschscholzia californica 6X HPUS
Gelsemium sempervirens 12X HPUS
Nux moschata 9X HPUS
Passiflora incarnata 6X HPUS
Piper methysticum 6X HPUS
Valeriana officinalis 6X HPUS
‡ Organic
"HPUS" indicates that this ingredient is officially included in the Homoeopathic Pharmacopoeia of the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SLEEPOLOGY
alfalfa, avena sativa, chamomilla, eschscholtzia californica, gelsemium sempervirens, nux moschata, passiflora incarnata, piper methysticum, valeriana officinalis tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69676-0012 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 6 [hp_X] ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA 6 [hp_X] ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X) ESCHSCHOLZIA CALIFORNICA 6 [hp_X] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X] NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 9 [hp_X] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (PIPER METHYSTICUM ROOT - UNII:BOW48C81XP) PIPER METHYSTICUM ROOT 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X] MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE 6 [hp_X] Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) CARNAUBA WAX (UNII: R12CBM0EIZ) MALTODEXTRIN (UNII: 7CVR7L4A2D) RICE BRAN (UNII: R60QEP13IC) Product Characteristics Color white (Off-white) Score no score Shape ROUND Size 10mm Flavor VANILLA Imprint Code G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69676-0012-1 1 in 1 CARTON 03/21/2016 1 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69676-0012-3 2 in 1 POUCH; Type 0: Not a Combination Product 10/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/21/2016 Labeler - Genexa Inc. (079751024)