Label: INSOMNIA- aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis spray
- NDC Code(s): 50845-0272-1, 50845-0272-2
- Packager: Liddell Laboratories, Inc.
- 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 October 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENTS:
(in each spray) 7.69% of Aquilegia Vulgaris 2X, Avena Sativa 2X, Chamomilla 2X, Coffea Cruda 6X, Cypripedium Pubescens 8X, Humulus Lupulus 3X, Hypericum Perforatum 6X, Kali Phosphoricum 12X, Melatonin 6X, Melissa Officinalis 3X, Natrum Muriaticum 30C, Passiflora Incarnata 2X, Valeriana Officinalis 2X.
- USES:
-
WARNINGS:
See box.
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Stop use and ask a doctor if symptoms persist for more than 7 days, worsen, or if new symptoms occur.
Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.
If pregnant or breast feeding, ask a doctor before using product.
Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.
Store at room temperature.
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- USES:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
-
INGREDIENTS AND APPEARANCE
INSOMNIA
aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0272 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2) AQUILEGIA VULGARIS 2 [hp_X] in 1 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 2 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 8 [hp_X] in 1 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 3 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 6 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 12 [hp_X] in 1 mL MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN 6 [hp_X] in 1 mL MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS WHOLE 3 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_C] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X] 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:50845-0272-2 1 in 1 CARTON 12/23/2020 1 NDC:50845-0272-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/23/2020 Labeler - Liddell Laboratories, Inc. (832264241) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50845-0272) , api manufacture(50845-0272) , label(50845-0272) , pack(50845-0272)
